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Background: Polycystic ovary syndrome (PCOS) is a common endocrine condition which affects women in the reproductive age group. South Asian women with PCOS have a higher risk of insulin resistance and metabolic disorder compared to women from other ethnic backgrounds. Lifestyle interventions such as dietary advice and physical exercise are recommended as a first-line management option for infertile women with PCOS. Most of the randomized controlled trials evaluating the role of lifestyle interventions in infertile PCOS women were characterized by methodological issues. The uptake of lifestyle modifications as a treatment strategy in the South Asian population is complicated by a difficult-to-change conventional high-carbohydrate diet and limited availability of space for physical activity in the region. Methods: The study is designed as an open-label, multicentre, randomized controlled trial in South Asian women with PCOS. Women attending the fertility clinic will be screened for eligibility, and women aged between 19 and 37 years who have been diagnosed with PCOS and wishing to conceive will be invited to participate in the trial. We will include women with body mass index (BMI) between ≥ 23 and ≤ 35 kg/m2 and duration of infertility ≤ 3 years. We plan to randomize women with PCOS into two groups: group A will receive the intervention which will consist of individualized advice on diet and physical exercise along with a telephonic reminder system and follow-up visits, and group B (control) will receive one-time advice on diet and physical exercise. Both groups will receive up to three cycles of ovulation induction with letrozole after 3 months of randomization during the 6-month treatment period. The primary outcome of the trial will be the live birth following conception during the intervention period. The secondary outcomes include clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, stillbirth, time to pregnancy, mean weight loss, differences in anthropometric parameters, improvement in menstrual regularity and quality of life score. Discussion: The IPOS trial results could help clarify and provide more robust evidence for advocating an individualized lifestyle intervention in PCOS women who wish to conceive. Trial registration: Clinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023. [ABSTRACT FROM AUTHOR]

There has been recent advocacy for food fortification with zinc in India. However, there are three important conditions that should be established before fortifying food with any micronutrient, which requires that there should be i) Established high prevalence of biochemical or sub-clinical deficiency (≥20%), ii) Low dietary intakes that increase the risk of deficiency, and iii) Evidence of efficacy of supplementation from clinical trials. For zinc, all three conditions are not satisfied. The prevalence of low serum zinc concentrations in Indian children is well below 20% (∼6%), signifying that zinc deficiency is not a public health problem. There is no risk of dietary zinc inadequacy in Indian populations where intake has been measured. Finally, there is no robust evidence that zinc-fortified foods improve functional outcomes, even if the serum zinc concentration is increased. Thus, contemporary evidence does not justify the need for food fortification with zinc in India. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Clinical biochemistry reference intervals (RIs) play a crucial role in interpreting patient test results and making informed clinical decisions. Using data from an ongoing Indian Council of Medical Research-National task force study on healthy women, normative ranges for commonly analyzed biochemical analytes were established. MATERIALS AND METHODS: A total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9898 women signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and comorbidities were excluded. RIs of 22 analytes were computed in the remaining 938 women controls. To estimate the 95% range of the reference distribution, the limits of the 2.5th percentile and the 97.5th percentile were used in the study. RESULTS: Mean ± standard deviation of age and body mass index of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. Centiles (2.5th-97.5th) of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters are presented. No significant difference in analytes was observed in relation to the area of residence, and age groups except in albumin (P = 0.03). The distribution of most of the parameters was consistent with the various RI studies conducted in India as well as other countries. CONCLUSION: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive-age women recruited using a robust design across the country. The resource may serve as a reference range for common biochemical analytes for future in this age group. [ABSTRACT FROM AUTHOR]

Population-based surveys commonly use point-of-care (POC) methods with capillary blood samples for estimating Hb concentrations; these estimates need to be validated by comparison with reference methods using venous blood. In a cross-sectional study in 748 participants (17–86 years, 708 women, Hb: 5·1 to 18·2 g/dl) from Hyderabad, India, we validated Hb measured from a pooled capillary blood sample by a POC autoanalyser (Horiba ABX Micros 60OT, Hb-C-AA) by comparison with venous blood Hb measured by two reference methods: POC autoanalyser (Hb-V-AA) and cyanmethemoglobin method (Hb-V-CM). These comparisons also allowed estimation of blood sample-related and equipment-related differences in the Hb estimates. We also conducted a longitudinal study in 426 participants (17–21 years) to measure differences in the Hb response to iron folate (IFA) treatment by the capillary blood POC method compared with the reference methods. In the cross-sectional study, Bland–Altman analyses showed trivial differences between source of blood (Hb-C-AA and Hb-V-AA; mean difference, limits of agreement: 0·1, −0·8 to 1·0 g/dl) and between analytical methods (Hb-V-AA and Hb-V-CM; mean difference, limits of agreement: < 0·1, −1·8 to 1·8 g/dl). Cross-sectional anaemia prevalence estimated using Hb-C-AA did not differ significantly from Hb-V-CM or Hb-V-AA. In the longitudinal study, the Hb increment in response to IFA intervention was not different when using Hb-C-AA (1·6 ± 1·7 g/dl) compared with Hb-V-AA (1·7 ± 1·7 g/dl) and Hb-V-CM (1·7 ± 1·7 g/dl). The pooled capillary blood–autoanalyzer method (Hb-C-AA) offers a practical and accurate way forward for POC screening of anaemia. [ABSTRACT FROM AUTHOR]

Age-related changes in fat and lean mass contribute to bone health, but these associations may be influenced by sex and ethnicity. This study investigated sex-specific associations of obesity and sarcopenia with bone mineral density (BMD) and bone mineral apparent density (BMAD) among Indian older adults. 1057 adults aged ≥ 50 years were included. Dual-energy X-ray absorptiometry (DXA) measured BMD at the hip, spine and whole-body, and BMAD was calculated as BMD/√bone area. Obesity was defined by body fat percentage (cut points; > 25% for men and > 35% for women), and sarcopenia was defined using the revised Asian Working Group for Sarcopenia classification with low hand grip strength (< 28 kg for men and < 18 kg for women) and appendicular lean mass index (< 7.0 kg/m2 for men and < 5.4 kg/m2 for women). Participants were classified into four groups: controls (no obesity or sarcopenia), obesity, sarcopenia, or sarcopenic obesity. Linear regression (β-coefficients and 95%CI) analyses were performed with adjustments for age, smoking status, protein intake, and socioeconomic status. Prevalence of sarcopenia (37%) and sarcopenic obesity (6%) were higher in men than women (17% and 4%, respectively). Compared with controls, men with obesity had lower whole-body BMD and BMAD, but women with obesity had higher hip and spine BMD and BMAD (all p < 0.05). Men, but not women, with sarcopenic obesity, had lower hip and whole-body BMD and BMAD (all p < 0.05) than controls. Men with sarcopenia had lower BMD and BMAD at the hip only, whereas women had lower BMD at all three sites and had lower BMAD at the hip and spine (all p < 0.05), compared with controls. Obesity, sarcopenia, and sarcopenic obesity have sex-specific associations with BMD and BMAD in Indian older adults. With the aging population in India, it is important to understand how body composition contributes to poor bone health among older adults. [ABSTRACT FROM AUTHOR]

Background: Modeling studies estimated severe impacts of potential service delivery disruptions due to COVID-19 pandemic on maternal and child nutrition outcomes. Although anecdotal evidence exists on disruptions, little is known about the actual state of service delivery at scale. We studied disruptions and restorations, challenges and adaptations in health and nutrition service delivery by frontline workers (FLWs) in India during COVID-19 in 2020. Methods: We conducted phone surveys with 5500 FLWs (among them 3118 Anganwadi Workers) in seven states between August–October 2020, asking about service delivery during April 2020 (T1) and in August-October (T2), and analyzed changes between T1 and T2. We also analyzed health systems administrative data from 704 districts on disruptions and restoration of services between pre-pandemic (December 2019, T0), T1 and T2. Results: In April 2020 (T1), village centers, fixed day events, child growth monitoring, and immunization were provided by <50% of FLWs in several states. Food supplementation was least disrupted. In T2, center-based services were restored by over a third in most states. Administrative data highlights geographic variability in both disruptions and restorations. Most districts had restored service delivery for pregnant women and children by T2 but had not yet reached T0 levels. Adaptations included home delivery (60 to 96%), coordinating with other FLWs (7 to 49%), and use of phones for counseling (~2 to 65%). Personal fears, long distances, limited personal protective equipment, and antagonistic behavior of beneficiaries were reported challenges. Conclusions: Services to mothers and children were disrupted during stringent lockdown but restored thereafter, albeit not to pre-pandemic levels. Rapid policy guidance and adaptations by FLWs enabled restoration but little remains known about uptake by client populations. As COVID-19 continues to surge in India, focused attention to ensuring essential services is critical to mitigate these major indirect impacts of the pandemic. [ABSTRACT FROM AUTHOR]

High prevalence of anaemia is a severe public health problem in India. In 2018, India launched the Anemia Mukt Bharat (AMB) strategy that focuses on six beneficiary groups for coverage, six institutional mechanisms for health system strengthening and six programmatic interventions to accelerate reductions in anaemia prevalence. This paper uses the Health Management Information System data (2017-18 to 2019-20) to examine gains in IFA coverage across Indian states. A coverage-based AMB index is computed to review performance across states. After the launch of AMB strategy, the Iron and Folic Acid (IFA) supplementation coverage between 2017-18 and 2019-20 has increased for all beneficiary groups [pregnant women from 78% to 90%; lactating mothers from 34% to 49%; school going adolescent girls (boys) from 23% to 40% (21% to 42%); out-of-school adolescent girls from 6% to 23%; children 5-9 years from 8% to 3% and children 6-59 months from 7% to 15%]. Coverage was relatively low for target groups being served through a multi-departmental convergence mechanism (health and other departments such as education department for schools or women and child development department for Anganwadi centres) than compared to those served by health department alone. However, no major gender disparities are noted in the coverage of IFA supplementation among school-going girls and boys. Bulk of the variations in coverage is attributable to state-specific differences. Training and sensitization workshops for state and district officials are found to be associated with increased coverage across beneficiary groups. The paper argues that despite following international best practices in the field, it is important to harness synergy in programme implementation across line departments to eliminate coverage inefficiencies. [ABSTRACT FROM AUTHOR]

Purpose: There are no representative estimates of vitamin A deficiency (VAD) and risk of vitamin A (VA) dietary inadequacy in Indian children and adolescents. To evaluate, from national surveys, the prevalence of VAD measured by serum retinol concentrations (< 0.7 µmol/L or < 20 µg/dL), and the risk of VA dietary inadequacy and excess intake beyond the tolerable upper limit (TUL). Methods: National and state-level VAD prevalence adjusted for inflammation was estimated in school-age children (5–9 years: 10,298) and adolescents (10–19 years: 9824) from the Comprehensive National Nutrition Survey (CNNS 2016-18). The risk of dietary inadequacy against age-specific average VA requirements, and excess intake against the TUL, was assessed from the National Sample Survey Office (NSSO 2014) data. Results: Serum retinol concentrations increased with age (5–19 years) in both genders and were significantly lower in school-age children (1.02 µmol/L, CI: 1.01–1.03) compared to adolescents (1.13 µmol/L, CI 1.12–1.15). The inflammation-adjusted prevalence of VAD in school-age children and adolescents was 19.3% (CI 18.8–19.9) and 14.4% (CI 13.9–14.9) respectively, and this was > 20% in seven and four states for children and adolescents, respectively. The prevalence of VAD was significantly higher among children with lower socio-economic status. The risk of dietary VA inadequacy, from the NSSO survey, was 69 and 78% in children and adolescents, respectively. This risk reduced to 6 and 17% with VA fortified oil and milk intake, while the proportion of intakes exceeding the TUL became 6 and 0.5% in children and adolescents, respectively. Conclusions: The national prevalence of VAD in school-age children and adolescents in India was just less than 20%. The risk of dietary VA deficiency is likely to decline substantially with VA fortified food intake, but a risk of excessive intake also begins to appear; therefore, a careful assessment of the risk of hypervitaminosis A is required at these ages. [ABSTRACT FROM AUTHOR]

Both ethnicity and age are important determinants of musculoskeletal health. We aimed to determine the prevalence of sarcopenia, assess the suitability of current diagnostic guidelines, and explore muscle-bone relationships in adults from India. A total of 1009 young (20–35 years) and 1755 older (> 40 years) men and women from existing studies were collated and pooled for the analysis. Dual-energy x-ray absorptiometry measured areal bone mineral density (aBMD) at the hip and spine, and fat and lean mass; hand dynamometer measured hand grip strength (HGS). Indian-specific cut-points for appendicular lean mass (ALM), ALM index (ALMI) and HGS were calculated from young Indian (-2SD mean) populations. Sarcopenia was defined using cut-points from The Foundations for the National Institutes of Health (FNIH), revised European Working Group on Sarcopenia in Older People (EWGSOP2), Asian Working Group for Sarcopenia (AWGS), and Indian-specific cut-points. Low lean mass cut-points were then compared for their predictive ability in identifying low HGS. The relationship between muscle variables (ALM, ALMI, HGS) and aBMD was explored, and sex differences were tested. Indian-specific cut-points (men-HGS:22.93 kg, ALM:15.41 kg, ALMI:6.03 kg/m2; women-HGS:10.76 kg, ALM:9.95 kg, ALMI:4.64 kg/m2) were lower than existing definitions. The Indian-specific definition had the lowest, while EWGSOP2 ALMI had the highest predictive ability in detecting low HGS (men:AUC = 0.686, women:AUC = 0.641). There were sex differences in associations between aBMD and all muscle variables, with greater positive associations in women than in men. The use of appropriate cut-points for diagnosing low lean mass and physical function is necessary in ethnic populations for accurate sarcopenia assessment. Muscle-bone relationships are more tightly coupled during ageing in Indian women than men. [ABSTRACT FROM AUTHOR]

When public health programs with single nutrients are perceived to have a poor impact on the target health outcome, the policy response can be to supply more , by layering additional mandatory programs upon the extant programs. However, we argue for extreme caution, because nutrients (like medicines) are beneficial in the right dose, but potentially harmful when ingested in excess. Unnecessary motivations for the reactionary layering of multiple intervention programs emerge from incorrect measurements of the risk of nutrient inadequacy in the population, or incorrect biomarker cutoffs to evaluate the extent of nutrient deficiencies. The financial and social costs of additional layered programs are not trivial when traded off with other vital programs in a resource-poor economy, and when public health ethical dilemmas of autonomy, equity, and stigma are not addressed. An example of this conundrum in India is the perception of stagnancy in the response of the prevalence of anemia to the ongoing pharmacological iron supplementation program. The reaction has been a policy proposal to further increase iron intake through mandatory iron fortification of the rice provided in supplementary feeding programs like the Integrated Child Development Services and the School Mid-Day Meal. This is in addition to the ongoing pharmacological iron supplementation as well as other voluntary iron fortifications, such as those of salt and manufactured food products. However, before supplying more, it is vital to consider why the existing program is apparently not working, along with consideration of the potential for excess intake and related harms. This is relevant globally, particularly for countries contemplating multiple interventions to address micronutrient deficiencies. Supplying more by layering multiple nutrient interventions, instead of doing it right , without thoughtful considerations of social, biological, and ethics frameworks could be counterproductive. The cure, then, might well become the malady. [ABSTRACT FROM AUTHOR]

Background: Anemia control programs in India focus mainly on the measurement of hemoglobin in response to iron-folic acid supplementation. However, representative national estimates of iron deficiency (ID) are not available.Objectives: The objective of the present study was to evaluate ID prevalence among children and adolescents (1-19 y) using nationally representative data and to examine the sociodemographic patterning of ID.Methods: Cross-sectional data from the Comprehensive National Nutrition Survey in children (1-4 y: n = 9635; 5-9 y: n = 11,938) and adolescents (10-19 y; n = 11,507) on serum ferritin (SF) and other biomarkers were analyzed to determine inflammation-adjusted ID prevalence [SF (μg/L): <12 in 1-4 y and <15 in 5-19 y] and its relation to sociodemographic indicators. Multiple-regression analyses were conducted to identify the exposure associations of iron status. In addition, the relation between SF and hemoglobin was assessed as an indicator of iron utilization in different wealth quintiles.Results: ID prevalence was higher in 1- to 4-y-old children (31.9%; 95% CI: 31.0%, 32.8%) and adolescent girls (30.4%; 95% CI: 29.3%, 31.5%) but lower in adolescent boys and 5- to 9-y-old children (11%-15%). In all age groups, ID prevalence was higher in urban than in rural participants (1-4 y: 41% compared with 29%) and in those from richer quintiles (1-4 y: 44% in richest compared with 22% in poorest), despite adjustment for relevant confounders. SF significantly interacted with the wealth index, with declining trends in the strength of association between hemoglobin and SF from the richest to the poorest groups suggesting impaired iron utilization for hemoglobin synthesis in poorer wealth quintiles.Conclusions: ID prevalence was indicative of moderate (in preschool children and adolescent girls) or mild (in 5- to 9-y-old children and adolescent boys) public health problem with significant variation by state and age. Focusing on increasing iron intake alone, without addressing the multiple environmental constraints related to poverty, may not result in intended benefits. [ABSTRACT FROM AUTHOR]

Background It is thought that there is a high risk of zinc deficiency in India, but there are no representative national estimates. Objectives We aimed to evaluate the national and state-level prevalence of low serum zinc concentrations (SZCs) in Indian children from the nationally representative Comprehensive National Nutrition Survey. Methods Prevalence of low SZC, adjusted for C-reactive protein, was estimated among preschool (1–4 y; n  = 7874) and school-age children (5–9 y; n  = 10,430) and adolescents (10–19 y; n  = 10,140), using SZC cutoffs defined by the International Zinc Nutrition Consultative Group. Results Prevalence of low SZC was high among adolescents (31.1%; 95% CI: 29.8%, 32.4%), compared with school-age (15.8%; 95% CI: 15.3%, 16.3%) or preschool children (17.4%; 95% CI: 16.7%, 18.0%). However, stratification of prevalence by fasting status or using an alternative lower SZC cutoff independent of fasting status led to a reduction in prevalence by 3.7% or 7.8% in children <10 y, respectively. The prevalence of low SZC was higher among rural preschool children, those belonging to households with poor socioeconomic status, and those with severe stunting or underweight. Preschool children with diarrhea (22.6%; 95% CI: 20.8%, 24.4%), productive cough (22.7%; 95% CI: 18.5%, 27.5%), or malaria/dengue (38.5%; 95% CI: 29.4%, 48.2%) in the 2 wk preceding the survey had a higher prevalence of low SZC than those without morbidity (16.5%; 95% CI: 15.9%, 17.2%; 17.6%; 95% CI: 16.9%, 18.2%; and 17.5%; 95% CI: 16.8%, 18.1%, respectively). Conclusions The national prevalence of low SZC among preschool (17%) or school-age children (16%) was <20%, which is considered the cutoff indicating a problem of public health significance; but there were variations by state and socioeconomic status. In adolescents, however, the prevalence of low SZC was 31%, which warrants further investigation. The association of low SZC with diarrhea in preschool children necessitates better coverage of Zn administration in the management of diarrhea. [ABSTRACT FROM AUTHOR]

Multiple micronutrient deficiencies (MNDs) co‐exist, often because of poor intakes and adversely impact health. Habitual diets were assessed in 300 school children (6–17 years old) recruited from two government schools by simple random sampling. Probability of adequacy (PA) for 11 micronutrients and mean probability of adequacy (MPA) was calculated. Haemoglobin, plasma ferritin, folic acid, vitamin B12 and C‐reactive protein were estimated. Descriptive statistics and regression analysis were used to estimate magnitude and factors associated with MNDs. The contribution of fortified foods and/or supplements in addressing inadequacies and excessive intakes was modelled. The PA ranged from 0.04 for folate to 0.70 for zinc, and the MPA was 0.27. Prevalence of anaemia (53%), iron deficiency (57%; ID), iron deficiency anaemia (38%; IDA), folate deficiency (24%) and B12 deficiency (43%) was high. Dietary inadequacy of iron, zinc and a low MPA was associated with anaemia and IDA. Inclusion of double fortified salt (DFS), fortified rice (FR) or iron folic acid (IFA) supplements individually in habitual diet reduced probability of iron inadequacy significantly from 82% to ≤13%. Inclusion of DFS and FR simultaneously led to disappearance of iron inadequacy, but risk of excessive intake increased to 16%. Inclusion of DFS, FR and IFA together increased risk of excess iron intake to 40%. Nevertheless, intakes of folate and B12 remained inadequate even with FR and/or IFA. These results indicate a high risk of dietary MNDs in children and suggest need for more systematic intake measurements in representative sample and adjustment of iron dosages to avoid excessive intakes. [ABSTRACT FROM AUTHOR]

Background: Undernutrition during intrauterine life and early childhood is hypothesised to increase the risk of cardiovascular disease (Developmental Origins of Health and Disease Hypothesis), but experimental evidence from humans is limited. This hypothesis has major implications for control of the cardiovascular disease epidemic in South Asia (home to a quarter of world's population), where a quarter of newborns have low birth weight. We investigated whether, in an area with prevalent undernutrition, supplemental nutrition offered to pregnant women and their offspring below the age of 6 years was associated with a lower risk of cardiovascular disease in the offspring when they were young adults.Methods and Findings: The Hyderabad Nutrition Trial was a community-based nonrandomised controlled intervention trial conducted in 29 villages near Hyderabad, India (1987-1990). Protein-calorie food supplement was offered daily to pregnant and lactating women (2.09 MJ energy and 20-25 g protein) and their offspring (1.25 MJ energy and 8-10 g protein) until the age of six years in the 15 intervention villages, but not in the 14 control villages. A total of 1,826 participants (949 from the intervention villages and 877 from the control villages, representing 70% of the cohort) at a mean age of 21.6 years (62% males) were examined between 2009 and 2012. The mean body mass index (BMI) of the participants was 20 kg/m2 and the mean systolic blood pressure was 115 mm Hg. The age, sex, socioeconomic position, and urbanisation-adjusted effects of intervention (beta coefficients and 95% confidence intervals) on outcomes were as follows: carotid intima-media thickness, 0.01 mm (-0.01 to 0.03), p = 0.36; arterial stiffness (augmentation index), -1.1% (-2.5 to 0.3), p = 0.097; systolic blood pressure, 0.5 mm Hg (-0.6 to 1.6), p = 0.36; BMI, -0.13 kg/m2 (-0.75 to 0.09), p = 0.093; low-density lipoprotein (LDL) cholesterol, 0.06 mmol/L (-0.07 to 0.2), p = 0.37; and fasting insulin (log), -0.06 mU/L (-0.19 to 0.07), p = 0.43. The limitations of this study include nonrandomised allocation of intervention and lack of data on compliance, and potential for selection bias due to incomplete follow-up.Conclusions: Our results showed that in an area with prevalent undernutrition, protein-calorie food supplements offered to pregnant women and their offspring below the age of 6 years were not associated with lower levels of cardiovascular risk factors among offspring when they were young adults. Our findings, coupled with evidence from other intervention studies to date, suggest that policy makers should attach limited value to cardiovascular health benefits of maternal and child protein-calorie food supplementation programmes. [ABSTRACT FROM AUTHOR]

Background: Evidence linking ambient air pollution with atherosclerosis is lacking from low- and middle-income countries. Additionally, evidence regarding the association between household air pollution and atherosclerosis is limited. We evaluated the association between ambient fine particulate matter [particulate matter with an aerodynamic diameter of ≤2.5 µm (PM2.5)] and biomass fuel use on carotid intima-media thickness (CIMT), a surrogate of atherosclerosis, in India.Methods: We analysed the third follow-up of the Andhra Pradesh Children and Parent Study cohort (2010-2012), which recruited participants from 28 peri-urban villages. Our primary outcome was mean CIMT, measured using a standardized protocol. We estimated annual average PM2.5 outdoors at residence using land-use regression. Biomass cooking fuel was self-reported. We fitted a within-between linear-mixed model adjusting for potential confounders.Results: Among 3278 participants (48% women, mean age 38 years), mean PM2.5 was 32.7 [range 24.4-38.2] µg/m3, and 60% used biomass. After confounder adjustment, we observed positive associations between within-village variation in PM2.5 and CIMT in all participants [1.79%, 95% confidence interval (CI), -0.31 to 3.90 per 1  µg/m3 of PM2.5] and in men (2.98%, 95% CI, 0.23-5.72, per 1  µg/m3 of PM2.5). Use of biomass cooking fuel was associated with CIMT in all participants (1.60%, 95% CI, -0.46 to 3.65), especially in women with an unvented stove (6.14%, 95% CI, 1.40-10.89). The point-estimate for the PM2.5 association was larger in sub-groups with higher cardiometabolic risk profile.Conclusions: Ambient and household air pollution were positively associated with CIMT in a peri-urban population of India, although with limited precision for some estimates. We observed differences in the association between ambient and household air pollution and CIMT by gender. [ABSTRACT FROM AUTHOR]

Aim: Although several risk factors contribute to the development of sarcopenia, whether preclinical atherosclerosis contributes to the risk of sarcopenia is not established. The present cross‐sectional study aimed to investigate if there is an association between preclinical atherosclerosis and muscle strength among two ethnic populations. Methods: Participants included individuals aged ≥40 years and enrolled in the third follow‐up examination of the Andhra Pradesh Children and Parents Study, India, and in the baseline assessments of the Nagasaki Islands Study, Japan. Preclinical atherosclerosis was evaluated by carotid intima‐media thickness, brachial‐ankle pulse wave velocity, cardio‐ankle vascular index. The association of carotid intima‐media thickness and pulse wave velocity/cardio‐ankle vascular index with handgrip strength (HGS) was analyzed separately in the sexes and for hypertensive status from the two cohorts using a multivariable linear regression model. Results: Data on a total of 1501 participants in India and 3136 participants in Japan were analyzed. Carotid intima‐media thickness was negatively associated with HGS in non‐hypertensive Indian men (B coefficient = −5.38, P = 0.036). Arterial stiffness was also associated with HGS in non‐hypertensive Indian men (B = −0.97, P = 0.001), but not in hypertensive Indian men. Same as Indian men, we found the significant associations between arterial stiffness and HGS in non‐hypertensive women in both India and Japan (B = −0.44, P = 0.020, B = −0.63, P = 0.016, respectively), but not in hypertensive women. Conclusions: The negative association between preclinical atherosclerosis and HGS was dominantly found in non‐hypertensive participants. Geriatr Gerontol Int 2018; 18: 1071–1078. [ABSTRACT FROM AUTHOR]

Objectives: Clinical biochemistry reference intervals (RIs) are essential benchmarks to interpret patient test results and make clinical decisions. In this study, data on healthy women collected in an ongoing ICMR-National task force study was used to establish normative ranges for common biochemical analytes. Methods: A total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9,898 women who signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and with comorbidities were excluded. RIs of 22 analytes were computed in remaining 938 women controls. The 95% of the reference distribution was estimated using 2.5th percentile and 97.5th percentile limits. Results: The mean ± SD of age and body mass index (BMI) of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. The median and 2.5th -97.5th percentiles of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters were computed. No significant difference in analytes were observed in relation to the area of residence, and age groups except in albumin (p = 0.03). The distributions for most of the parameters were consistent with the various reference interval studies conducted in India as well as other countries. Conclusion: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive age women recruited using a robust design across the country. The resource may serve as reference range for common biochemical analytes for future in this age group. [ABSTRACT FROM AUTHOR]

Background: India's elderly population is rising at an unprecedented rate, with a majority living in rural areas. Health challenges associated with ageing, changing social networks and limited public health infrastructure are issues faced by the elderly and caregivers. We examined perceptions of health needs of the elderly across local stakeholders in an urbanizing rural area.Methods: The qualitative study was conducted among participants in the Andhra Pradesh Children and Parents Study (APCAPS) site in Rangareddy district, Telangana. We collected data using focus group discussions and interviews among communities (n = 6), health providers (n = 9) and administrators (n = 6). We assessed stakeholders' views on the influence of urbanization on health issues faced and interventions for alleviating these challenges. We used a conceptual-analytical model to derive themes and used an inductive approach to organizing emerging codes as per a priori themes. These were organized as per thematic groups and ranked by different authors in order of importance. Bronfebrenner's theory was used to understand stakeholder perspectives and suggest interventions within four identified spheres of influence - individual, household, community and services.Results: Stakeholders reported frailty, lack of transport and dependence on others as factors impacting health access of the elderly. Existing public health systems were perceived as overburdened and insensitive towards the elderly. Urbanization was viewed positively, but road accidents, crime and loneliness were significant concerns. Interventions suggested by stakeholders included health service outreach, lifestyle counseling, community monitoring of healthcare and engagement activities.Conclusions: We recommend integrating outreach services and lifestyle counseling within programs for care of the elderly. Community institutions can play an important role in the delivery and monitoring of health and social services for the elderly. [ABSTRACT FROM AUTHOR]

Osteoporosis and cardiovascular disease (CVD) share common risk factors, yet both are usually underdiagnosed in the absence of major complications. We investigated associations between arterial stiffness, cardiac workload, carotid intima media thickness (CIMT) and areal bone mineral density (aBMD) in Indian adults. Men and women aged >45 years from the Andhra Pradesh Children and Parents Study (APCAPS) were included for cross-sectional analysis (521 women and 696 men). Dual energy x-ray absorptiometry (DXA) measured aBMD at the whole body, total hip and lumbar spine. Supine blood pressure and heart rate were measured and used to calculate rate pressure product and pulse pressure; augmentation index, pulse wave velocity and CIMT were measured. Sex-interactions were tested (denoted as p-int); adjustments were made for confounders. Data were expressed as SD differences with 95 % confidence intervals. There were significant negative associations between pulse pressure and aBMD at all sites in women only. In unadjusted analyses, for every 1SD increase in pulse pressure, women had greater negative differences in aBMD at the whole body (−0.13 vs 0.007), total hip (−0.20 vs −0.05) and lumbar spine (−0.12 vs 0.05) compared with men. After adjustments, sex differences remained. Similar negative associations were seen between pulse wave velocity and augmentation index with aBMD in women only. There were no sex differences between CIMT and rate pressure product with aBMD. Markers of arterial stiffness are associated with poorer bone health in Indian women, but not in men. There is a need to identify the shared risk factors and markers of arterial stiffness and poor bone health to detect those who require co-management of these diseases to prevent cardiovascular events and fractures. • There are sex differences in cardiac and bone health associations in India. • Arterial stiffness is associated with poorer bone health in Indian women, not men. • Identifying shared risk factors is critical for co-management of CVD and bone health. [ABSTRACT FROM AUTHOR]

Background: There is limited availability of context-specific physical activity questionnaires in low and middle income countries. The aim of this study was to develop and examine the validity of a new Indian physical activity questionnaire, the Andhra Pradesh Children and Parent Study Physical Activity Questionnaire (APCAPS-PAQ).Methods: The current study was conducted with the cohort from the Hyderabad DXA Study (n = 2321), recruited in 2009-2010. Criterion validity (n = 245) was examined by comparing the APCAPS-PAQ to a combined heart rate and motion sensor worn for 8 days. Construct validity (n = 2321) was assessed with linear regression, comparing APCAPS-PAQ against BMI, percent body fat, and pulse rate.Results: The APCAPS-PAQ criterion validity was variable depending on the PA intensity groups (ρ = 0.26, 0.07, 0.39; к = 0.14, 0.04, 0.16 for sedentary, light, moderate/vigorous physical activity (MVPA) respectively). Sedentary and light intensity activities from the questionnaire were underestimated when compared to the criterion data while MVPA in APCAPS-PAQ was overestimated. Higher time spent in sedentary activity in APCAPS-PAQ was associated with higher BMI and percent body fat, suggesting construct validity.Conclusions: The APCAPS-PAQ validity is comparable to other physical activity questionnaires. This tool is able to assess sedentary behavior, moderate/vigorous activity and physical activity energy expenditure on a group level with reasonable validity. This new questionnaire may be used for ranking individuals according to their sedentary time and physical activity in southern India. [ABSTRACT FROM AUTHOR]

Background: Obesity is a growing health problem in India and worldwide, due to changes in lifestyle. This study aimed to explore the independent associations between dietary and physical activity exposure variables and total body fat and distribution in an Indian setting. Methods: Individuals who had participated in the Indian Migration Study (IMS) or the Andhra Pradesh Children And Parents' Study (APCAPS), were invited to participate in the Hyderabad DXA Study. Total and abdominal body fat of study participants was measured using DXA scans. Diet and physical activity (PA) levels were measured using questionnaires. Results: Data on 2208 participants was available for analysis; mean age was 49 yrs in IMS, 21 yrs in APCAPS. Total energy intake was positively associated with total body fat in the APCAPS sample: a 100 kcal higher energy intake was associated with 45 g higher body fat (95% CI 22, 68). In the IMS sample no association was found with total energy intake, but there was a positive association with percent protein intake (1% higher proportion of energy from protein associated with 509 g (95% CI 138,880) higher total body fat). Broadly the same pattern of associations was found with proportion of fat in the abdominal region as the outcome. PA was inversely associated with total body fat in both populations (in APCAPS, one MET-hour higher activity was associated with 46 g (95% CI 12, 81) less body fat; in the IMS it was associated with 145 g less body fat (95% CI 73, 218)). An inverse association was observed between PA and percentage abdominal fat in the IMS but no association was seen in the APCAPS population. Conclusions: In this Indian population, there was an inverse association between PA and body fat. Associations between body fat and dietary variables differed between the younger APCAPS population and older IMS population. Further longitudinal research is needed to elucidate causality and directions of these associations across the life course. [ABSTRACT FROM AUTHOR]

Dual-energy X-ray absorptiometry (DXA) and isotope dilution technique have been used as reference methods to validate the estimates of body composition by simple field techniques; however, very few studies have compared these two methods. We compared the estimates of body composition by DXA and isotope dilution (18O) technique in apparently healthy Indian men and women (aged 19–70 years, n 152, 48 % men) with a wide range of BMI (14–40 kg/m2). Isotopic enrichment was assessed by isotope ratio mass spectroscopy. The agreement between the estimates of body composition measured by the two techniques was assessed by the Bland–Altman method. The mean age and BMI were 37 (sd 15) years and 23·3 (sd 5·1) kg/m2, respectively, for men and 37 (sd 14) years and 24·1 (sd 5·8) kg/m2, respectively, for women. The estimates of fat-free mass were higher by about 7 (95 % CI 6, 9) %, those of fat mass were lower by about 21 (95 % CI − 18, − 23) %, and those of body fat percentage (BF%) were lower by about 7·4 (95 % CI − 8·2, − 6·6) % as obtained by DXA compared with the isotope dilution technique. The Bland–Altman analysis showed wide limits of agreement that indicated poor agreement between the methods. The bias in the estimates of BF% was higher at the lower values of BF%. Thus, the two commonly used reference methods showed substantial differences in the estimates of body composition with wide limits of agreement. As the estimates of body composition are method-dependent, the two methods cannot be used interchangeably. [ABSTRACT FROM PUBLISHER]

The Andhra Pradesh Children and Parents Study (APCAPS) was originally established to study the long-term effects of early-life undernutrition on risk of cardiovascular disease. Its aims were subsequently expanded to include trans-generational influences of other environmental and genetic factors on chronic diseases in rural India. It builds on the Hyderabad Nutrition Trial (HNT) conducted in 1987–90 to compare the effects on birthweight of a protein-calorie supplement for pregnant women and children. The index children of HNT and their mothers were retraced and examined in 2003–05, and the children re-examined as young adults aged 18–21 years in 2009–10. The cohort was expanded to include both parents and siblings of the index children in a recently completed follow-up conducted in 2010–12 (N = ∼6225 out of 10 213 participants). Recruitment of the remaining residents of these 29 villages (N = ∼55 000) in Ranga Reddy district of Andhra Pradesh is now under way. Extensive data on socio-demographic, lifestyle, medical, anthropometric, physiological, vascular and body composition measures, DNA, stored plasma, and assays of lipids and inflammatory markers on APCAPS participants are available. Details of how to access these data are available from the corresponding author. [ABSTRACT FROM AUTHOR]

Background: Undernutrition and physical inactivity are both associated with lower bone mass. Objective: This study aimed to investigate the combined effects of early-life undernutrition and urbanized lifestyles in later life on bone mass accrual in young adults from a rural community in India that is undergoing rapid socioeconomic development. Design: This was a prospective cohort study of participants of the Hyderabad Nutrition Trial (1987-1990), which offered balanced protein-calorie supplementation to pregnant women and preschool children younger than 6 y in the intervention villages. The 2009-2010 follow-up study collected data on current anthropometric measures, bone mineral density (BMD) measured by dual-energy X-ray absorptiometry, blood samples, diet, physical activity, and living standards of the trial participants (n = 1446, aged 18-23 y). Results: Participants were generally lean and had low BMD [mean hip BMD: 0.83 (women), 0.95 (men) g/cm²; lumbar spine: 0.86 (women), 0.93 (men) g/cm²]. In models adjusted for current risk factors, no strong evidence of a positive association was found between BMD and early-life supplementation. On the other hand, current lean mass and weight-bearing physical activity were positively associated with BMD. No strong evidence of an association was found between BMD and current serum 25-hydroxyvitamin D or dietary intake of calcium, protein, or calories. Conclusions: Current lean mass and weight-bearing physical activity were more important determinants of bone mass than was early-life undernutrition in this population. In transitional rural communities from low-income countries, promotion of physical activity may help to mitigate any potential adverse effects of early nutritional disadvantage. [ABSTRACT FROM AUTHOR]

In the present study, we examined the associations of early nutrition with adult lean body mass (LBM) and muscle strength in a birth cohort that was established to assess the long-term impact of a nutrition program. Participants (n = 1,446, 32% female) were born near Hyderabad, India, in 29 villages from 1987 to 1990, during which time only intervention villages (n = 15) had a government program that offered balanced protein-calorie supplementation to pregnant women and children. Participants’ LBM and appendicular skeletal muscle mass were measured using dual energy x-ray absorptiometry; grip strength and information on lifestyle indicators, including diet and physical activity level, were also obtained. Ages (mean = 20.3 years) and body mass indexes (weight (kg)/height (m)2; mean = 19.5) of participants in 2 groups were similar. Current dietary energy intake was higher in the intervention group. Unadjusted LBM and grip strength were similar in 2 groups. After adjustment for potential confounders, the intervention group had lower LBM (β = −0.75; P = 0.03), appendicular skeletal muscle mass, and grip strength than did controls, but these differences were small in magnitude (<0.1 standard deviation). Multivariable regression analyses showed that current socioeconomic position, energy intake, and physical activity level had a positive association with adult LBM and muscle strength. This study could not detect a “programming” effect of early nutrition supplementation on adult LBM and muscle strength. [ABSTRACT FROM PUBLISHER]

Objective: Abdominal adiposity is an important risk factor for diabetes and cardiovascular disease in Indians. Dual energy Xray absorptiometry (DXA) can be used to determine abdominal fat depots, being more accessible and less costly than gold standard measures such as magnetic resonance imaging (MRI). DXA has not been fully validated for use in South Asians. Here, we determined the accuracy of DXA for measurement of abdominal fat in an Indian population by comparison with MRI. Design: 146 males and females (age range 18-74, BMI range 15-46 kg/m2) from Hyderabad, India underwent whole body DXA scans on a Hologic Discovery A scanner, from which fat mass in two abdominal regions was calculated, from the L1 to L4 vertebrae (L1L4) and from the L2 to L4 vertebrae (L2L4). Abdominal MRI scans (axial T1-weighted spin echo images) were taken, from which adipose tissue volumes were calculated for the same regions. Results: Intra-class correlation coefficients between DXA and MRI measures of abdominal fat were high (0.98 for both regions). Although at the level of the individual, differences between DXA and MRI could be large (95% of DXA measures were between 0.8 and 1.4 times MRI measures), at the sample level, DXA only slightly overestimated MRI measures of abdominal fat mass (mean difference in L1L4 region: 2% (95% CI:0%, 5%), mean difference in L2L4 region:4% (95% CI: 1%, 7%)). There was evidence of a proportional bias in the association between DXA and MRI (correlation between difference and mean 20.3), with overestimation by DXA greater in individuals with less abdominal fat (mean bias in leaner half of sample was 6% for L1L4 (95%CI: 2, 11%) and 7% for L2L4 (95% CI:3,12%). Conclusions: DXA measures of abdominal fat are suitable for use in Indian populations and provide a good indication of abdominal adiposity at the population level. [ABSTRACT FROM AUTHOR]

Objective: To examine the catch up growth in severely wasted children using energy dense local foods at a hospital based nutrition rehabilitation unit. Design: Retrospective cohort. Setting: In-patient ward at a tertiary care government pediatric hospital in Hyderabad. Patients: Children with severe malnutrition (n=309) admitted to nutrition ward from January 2001 to December 2005. Intervention: A diet based on energy dense local foods along with multivitamin-multimineral supplements. Main outcome measures: Catch up growth (g/kg/day) during each week of hospital stay. Results: Mean age of the children was 25 months (range 2-60). Their baseline weight for height (WHZ) Z score was -4.1. Mean weight gain was moderate (5g/kg/day) and baseline WHZ score had a significant negative relationship to the weight gain. The prevalence of morbidities was high and the commonest morbidity was fever. Weight gain was higher by almost 40% in the absence of morbidities in any week. Conclusions: The diet based on local energy dense foods was found to be suitable for the nutrition rehabilitation of severely malnourished children though the rate of weight gain was moderate. [ABSTRACT FROM AUTHOR]

Concerns are raised that rapid catch up growth during nutrition rehabilitation of severely malnourished children may be associated with disproportionately higher amounts of body fat deposition. This study examined the composition of weight gain in severely undernourished children who underwent nutrition rehabilitation in a hospital from India. Body composition of 80 severely malnourished children (age 6-60 months) was assessed using skinfold thickness measurements on admission and after 1 month of supplementary feeding. On admission, children bad severe weight and height deficits and were severely wasted. The mean weight for age z score, height for age z score and weight for height z score (WHZ) were -5.0, -4.2 and -4.1 respectively. Children consumed a mixed diet and mean energy intake was 177 kcal/kg/day with a protein energy ratio of 13. Overall, the mean weight gain was 6,1 g/kg/day and fat mass contributed to about 40% of the weight gain. When the composition of weight gain was analysed in tertiles of baseline WHZ score, children in the lowest tertile of WHZ score had significantly higher weight gain and fat free mass (FFM) gain. Gain in fat mass did not differ in relation to the baseline WHZ score. The study demonstrates that it is possible to achieve rapid weight gain with recovery of lost tissue in severely malnourished children with mixed diets. Children with lowest WHZ scores at baseline gained higher FFM during nutrition rehabilitation when compared to the children with relatively higher WHZ score probably in an attempt to recover the lost tissue. [ABSTRACT FROM AUTHOR]

The article reviews the book "Balanche Aajar Va Shalyachikitsa," by Dr. Minakshi Nalbale Bhosale.

Objective: To examine prevalence, risk factors, and consequences of maternal severe thinness in India.Methods: This mixed methods study analyzed data from the Indian National Family Health Survey (NFHS)-4 (2015-2016) to estimate the prevalence of and risk factors for severe thinness, followed by a desk review of literature from India.Results: Prevalence of severe thinness (defined by World Health Organization as body mass index [BMI] <16 in adult and BMI for age Z score < -2 SD in adolescents) was higher among pregnant adolescents (4.3%) compared with pregnant adult women (1.9%) and among postpartum adolescent women (6.3%) than postpartum adult women (2.4%) 2-6 months after delivery. Identified research studies showed prevalence of 4%-12% in pregnant women. Only 13/640 districts had at least three cases of severely thin pregnant women; others had lower numbers. Three or more postpartum women aged ≥20 years were severely thin in 32 districts. Among pregnant adolescents, earlier parity increased odds (OR 1.96; 95% CI, 1.18-3.27) of severe thinness. Access to household toilet facility reduced odds (OR 0.72; 95% CI, 0.52-0.99]. Among mothers aged ≥20 years, increasing education level was associated with decreasing odds of severe thinness (secondary: OR 0.74; 95% CI, 0.57-0.96 and Higher: OR 0.54; 95% CI, 0.32-0.91, compared with no education); household wealth and caste were also associated with severe thinness.Conclusion: This paper reveals the geographic pockets that need priority focus for managing severe thinness among pregnant women and mothers in India to limit the immediate and intergenerational adverse consequences emanating from these deprivations. [ABSTRACT FROM AUTHOR]

This paper answers research questions on screening and management of severe thinness in pregnancy, approaches that may potentially work in India, and what more is needed for implementing these approaches at scale. A desk review of studies in the last decade in South Asian countries was carried out collating evidence on six sets of strategies like balanced energy supplementation (BEP) alone and in combination with other interventions like nutrition education. Policies and guidelines from South Asian countries were reviewed to understand the approaches being used. A 10-point grid covering public health dimensions covered by World Health Organization and others was created for discussion with policymakers and implementers, and review of government documents sourced from Ministry of Health and Family Welfare. Eighteen studies were shortlisted covering Bangladesh, India, Nepal, and Pakistan. BEP for longer duration, preconception initiation of supplementation, and better pre-supplementation body mass index (BMI) positively influenced birthweight. Multiple micronutrient supplementation was more effective in improving gestational weight gain among women with better pre-supplementation BMI. Behavior change communication and nutrition education showed positive outcomes on dietary practices like higher dietary diversity. Among South Asian countries, Sri Lanka and Nepal are the only two countries to have management of maternal thinness in their country guidelines. India has at least nine variations of supplementary foods and three variations of full meals for pregnant women, which can be modified to meet additional nutritional needs of those severely thin. Under the National Nutrition Mission, almost all of the globally recommended maternal nutrition interventions are covered, but the challenge of reaching, identifying, and managing cases of maternal severe thinness persists. This paper provides four actions for addressing maternal severe thinness through available public health programs, infrastructure, and human resources. [ABSTRACT FROM AUTHOR]

• The evidence for the effects of air pollution on lung function of young adults is scarce. • We evaluated annual average PM 2.5 outdoors at residence and biomass cooking fuel. • We observed negative associations for ambient PM 2.5 and biomass cooking fuel and lung function, although imprecise for ambient PM 2.5. Although there is evidence for the association between air pollution and decreased lung function in children, evidence for adolescents and young adults is scarce. For a peri-urban area in India, we evaluated the association of ambient PM 2.5 and household air pollution with lung function for young adults who had recently attained their expected maximum lung function. We measured, using a standardized protocol, forced expiratory volume in the first second (FEV 1) and forced vital capacity (FVC) in participants aged 20–26 years from the third follow-up of the population-based APCAPCS cohort (2010–2012) in 28 Indian villages. We estimated annual average PM 2.5 outdoors at residence using land-use regression. Biomass cooking fuel (a proxy for levels of household air pollution) was self-reported. We fitted a within-between linear-mixed model with random intercepts by village, adjusting for potential confounders. We evaluated 1,044 participants with mean age of 22.8 (SD = 1) years (range 20–26 years); 327 participants (31%) were female. Only males reported use of tobacco smoking (9% of all participants, 13% of males). The mean ambient PM 2.5 exposure was 32.9 (SD = 2.8) µg/m3; 76% reported use of biomass as cooking fuel. The adjusted association between 1 µg/m3 increase in PM 2.5 was −27 ml (95% CI, −89 to 34) for FEV 1 and −5 ml (95% CI, −93 to 76) for FVC. The adjusted association between use of biomass was −112 ml (95% CI, −211 to −13) for FEV 1 and −142 ml (95% CI, −285 to 0) for FVC. The adjusted association was of greater magnitude for those with unvented stove (−158 ml, 95% CI, −279 to −36 for FEV 1 and −211 ml, 95% CI, −386 to −36 for FVC). We observed negative associations between ambient PM 2.5 and household air pollution and lung function in young adults who had recently attained their maximum lung function. [ABSTRACT FROM AUTHOR]

• We evaluated personal exposure to PM 2.5 and BC in adults from peri-urban India. • PM 2.5 was associated with vascular damage by three cardiovascular markers in men. • PM 2.5 was nonlinearly associated with increased augmentation index in men. • Both PM 2.5 and BC were positively associated with augmentation index AIx in women. Air pollution is a leading preventable risk factor for cardiovascular diseases. Previous studies mostly relied on concentrations at residence, which might not represent personal exposure. Personal air pollution exposure has a greater variability compared with levels of ambient air pollution, facilitating evaluation of exposure-response functions and vascular pathophysiology. We aimed to evaluate the association between predicted annual personal exposure to PM 2.5 and black carbon (BC) and three vascular damage markers in peri-urban South India. We analyzed the third wave of the APCAPS cohort (2010–2012), which recruited participants from 28 villages. We used predicted personal exposure to PM 2.5 and BC derived from 610 participant-days of 24 h average gravimetric PM 2.5 and BC measurements and predictors related to usual time-activity. Outcomes included carotid intima-media thickness (CIMT), carotid-femoral pulse wave velocity (cf-PWV) and augmentation index (AIx). We fit linear mixed models, adjusting for potential confounders and accounting for the clustered data structure. We evaluated nonlinear associations using generalized additive mixed models. Of the 3017 participants (mean age 38 years), 1453 (48%) were women. The average PM 2.5 exposure was 51 µg/m3 (range 13–85) for men, and 61 µg/m3 (range 40–120) for women, while the average BC was 4 µg/m3 (range 3–7) for men and 8 µg/m3 (range 3–22) for women. A 10 μg/m3 increase of PM 2.5 was positively associated with CIMT (0.026 mm, 95% CI 0.014, 0.037), cf-PWV (0.069 m/s, 95% CI 0.008, 0.131) and AIx (0.8%, 95% CI 0.3, 1.3) among men. The exposure-response function for PM 2.5 and AIx among men showed non-linearity, particularly within the exposure range dominated by tobacco smoking and occupational exposures. Both PM 2.5 and BC were positively associated with AIx among women (0.6%, 95% CI 0.2, 1.0, per 10 μg/m3 PM 2.5 ; 0.5%, 95% CI 0.1, 0.8, per 2 μg/m3 BC). Personal exposure to particulate matter was associated with vascular damage in a peri-urban population in South India. Personal exposure to particulate matter appears to have gender-specific effects on the type of vascular damage, potentially reflecting differences in sources of personal exposure by gender. [ABSTRACT FROM AUTHOR]

• We present an index, WENI, to measure women's empowerment in the realm of nutrition. • WENI can be used to measure, track and identify barriers to nutritional empowerment. • We use the Alkire-Foster approach to construct the index for two sites in India. • WENI is a good predictor of dietary diversity, body mass index and anemia for our sample. Rural women face many obstacles that thwart their well-being. Policies that seek to empower them, for example, by improving livelihood opportunities, often do not translate into improvements in other areas, notably in their nutritional status. Indeed, many existing measures of women's empowerment have ambiguous associations with indicators of nutritional status. This is likely because existing operationalizations of empowerment often focus on aspects that are somewhat distal from factors that influence nutrition. In this paper, we present an index that aims to measure women's empowerment in the realm of nutrition. We define nutritional empowerment as the process by which individuals acquire the capacity to be well fed and healthy, in a context where this capacity was previously denied to them. Our index draws on theory and multi-site formative research from South Asia and captures multiple dimensions of empowerment spanning domains that influence nutritional outcomes. We construct this index using data from two sites in India and validate it by estimating two nutritional outcomes, body mass index (BMI) and anemia, as a function of the index. We find that our index is significantly associated with these outcomes, indicating that, in rural South Asia, the women's empowerment in nutrition index can assist researchers to understand the nutritional status of women and their families. [ABSTRACT FROM AUTHOR]

There has been increasing interest in associations between neighborhood food environments and cardiovascular risk factors. However, results from high-income countries remain inconsistent, and there has been limited research from low- and middle-income countries. We conducted a cross-sectional analysis of the third wave follow-up of the Andhra Pradesh children and parents study (APCAPS) (n = 5764, median age 28.8 years) in south India. We examined associations between the neighborhood availability (vendor density per km2 within 400 m and 1600 m buffers of households) and accessibility (distance from the household to the nearest vendor) of fruit/vegetable and highly processed/take-away food vendors with 11 cardiovascular risk factors, including adiposity measures, glucose-insulin, blood pressure, and lipid profile. In fully adjusted models, higher density of fruit/vegetable vendors within 400 m of participant households was associated with lower systolic blood pressure [−0.09 mmHg, 95% confidence interval (CI): −0.17, −0.02] and diastolic blood pressure (−0.10 mmHg, 95% CI: −0.17, −0.04). Higher density of highly processed/take-away food vendors within 400 m of participant households was associated with higher Body Mass Index (0.01 Kg/m2, 95% CI: 0.00, 0.01), waist circumference (0.22 mm, 95% CI: 0.05, 0.39), systolic blood pressure (0.03 mmHg, 95% CI: 0.01, 0.06), and diastolic blood pressure (0.03 mmHg, 95% CI: 0.01, 0.05). However, within 1600 m buffer, only association with blood pressure remained robust. No associations were found for between neighborhood accessibility and cardiovascular risk factors. Lower density of fruit/vegetable vendors, and higher density of highly processed/take-away food vendors were associated with adverse cardiovascular risk profiles. Public health policies regarding neighborhood food environments should be encouraged in south India and other rural communities in south Asia. • Greater density of healthy food vendors was associated with lower blood pressure. • Greater density of unhealthy food vendors was associated with higher blood pressure. • Greater density of unhealthy food vendors was associated with higher adiposity. • Public health policies modifying neighborhood food environments should be encouraged. [ABSTRACT FROM AUTHOR]

Limited evidence exists on the effect of particulate air pollution on blood glucose levels. We evaluated the associations of residential and personal levels of fine particulate matter (PM 2.5) and black carbon (BC) with blood glucose and diabetic status among residents of 28 peri-urban villages in South India. We used cross-sectional data from 5065 adults (≥18 years, 54% men) included in the Andhra Pradesh Children and Parents Study. Fasting plasma glucose was measured once in 2010–2012 and prevalent prediabetes and diabetes were defined following the American Diabetes Association criteria. We estimated annual ambient PM 2.5 and BC levels at residence using land-use regression models and annual personal exposure to PM 2.5 and BC using prediction models based on direct measurements from a subsample of 402 participants. We used linear and logistic nested mixed-effect models to assess the association between exposure metrics and health outcomes. For personal exposures, we stratified analyses by sex. Mean (SD) residential PM 2.5 and BC were 32.9 (2.6) μg/m3 and 2.5 (2.6) μg/m3, respectively; personal exposures to PM 2.5 and BC were 54.5 (11.5) μg/m3 and 5.8 (2.5) μg/m3, respectively. Average (SD) fasting blood glucose was 5.3 (1.3) mmol/l, 16% of participants had prediabetes, and 5.5% had diabetes. Residential PM 2.5 and BC were not associated with higher blood glucose levels. Personal PM 2.5 (20 μg/m3 increase) and BC (1 μg/m3 increase) were negatively associated with blood glucose levels in women (PM 2.5 : −1.93, 95%CI: −3.12, −0.73; BC: −0.63, 95%CI: −0.90, −0.37). In men, associations were negative for personal PM 2.5 (−1.99, 95%CI: −3.56, −0.39) and positive for personal BC (0.49, 95%CI: −0.44, 1.43). We observed no evidence of associations between any exposure and prevalence of prediabetes/diabetes. Our results do not provide evidence that residential exposures to PM 2.5 or BC are associated with blood glucose or prevalence of prediabetes/diabetes in this population. Associations with personal exposure may have been affected by unmeasured confounding, highlighting a challenge in using personal exposure estimates in air pollution epidemiology. These associations should be further examined in longitudinal studies. • We evaluated long-term air pollution exposure in adults from peri-urban India. • Ambient air pollution was not associated with higher blood glucose levels. • Personal air pollution exposure was associated with lower blood glucose levels. • We observed no associations between PM 2.5 /BC and prevalence of prediabetes/diabetes. [ABSTRACT FROM AUTHOR]

Background: Body mass index (BMI) is an important indicator of human health. However, trends in socioeconomic inequalities in BMI over time throughout India are understudied. Filling this gap will elucidate which socioeconomic groups are still at risk for adverse BMI values., Methods: This repeated cross-sectional study analysed four rounds of India's National Family Health Surveys (1998-1999, 2005-2006, 2015-2016, and 2019-2021). The outcome was BMI categories, measured in kilogram per metres squared (kg/m 2 ), defined as severely/moderately thin (<17.0 kg/m 2 ), mildly thin (17.0-18.4 kg/m 2 ), normal (18.5-24.9 kg/m 2 ), overweight (25.0-29.9 kg/m 2 ), and obese (≥30.0 kg/m 2 ). We examined the prevalence, standardised absolute change, and odds ratios estimated by multivariable regression models by household wealth and levels of education, two important measures of socioeconomic status (SES)., Results: The study population consisted of 1 244 149 women and 227 585 men. We found that those in the lowest SES categories were more likely to be severely/moderately thin or mildly thin. Conversely, those in the highest SES groups were more likely to be overweight or obese. The gradients were steepest for wealth, and this was substantiated by the results of regression models for every wave. There has been a decline in the difference in the prevalence of severely/moderately thin or mildly thin between SES groups when comparing the years 1999 and 2021., Conclusions: SES-based inequalities in BMI were smaller in 2021 compared to 1999. However, those in low SES groups were most likely to be severely/moderately thin or mildly thin while those in high SES groups were more likely to be overweight or obese. Future research should explore the pathways that link SES with BMI., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2024 by the Journal of Global Health. All rights reserved.)

Importance: The prevalence of polycystic ovary syndrome (PCOS) varies across the globe. Indian studies on PCOS are limited by poor design, small sizes, regional representations, and varying methods., Objectives: To estimate the nationwide prevalence of PCOS in India, examine the phenotypic spectrum, and assess the magnitude of comorbidities associated with PCOS., Design, Setting, and Participants: This cross-sectional study recruited 9824 women aged 18 to 40 years from November 1, 2018, to July 31, 2022, across 5 zones of the country. A prevalidated questionnaire dichotomized women into screen-positive and screen-negative groups. Relevant clinical, hormonal, and sonographic assessments categorized women as either women with criteria-based PCOS (ie, National Institutes of Health [NIH] 1990 criteria, Rotterdam 2003 criteria, or Androgen Excess and Polycystic Ovary Syndrome Society [AE-PCOS] criteria), women with partial phenotypes (hyperandrogenism, oligomenorrhea, or polycystic morphology labeled as pre-PCOS), or healthy women, in addition to quantitating various comorbidities., Main Outcomes and Measures: The prevalence and phenotypes of PCOS among women of reproductive age and the burden of comorbidities associated with PCOS., Results: A total of 8993 women (mean [SD] age, 29.5 [6.2] years) were enrolled in this study; 196 women were already diagnosed with PCOS, 2251 were categorized as screen positive, and 6546 were categorized as screen negative. The mean (SD) age of screen-positive women (28.1 [6.4] years) was lower than that of screen-negative women (29.7 [6.1] years) (P < .001), and the mean (SD) age at menarche was higher in the former group (13.2 [1.3] vs 13.1 [1.2] years; P < .001). The national prevalence of PCOS was 7.2% (95% CI, 4.8%-10.8%) by NIH 1990 criteria, 19.6% (95% CI, 12.7%-29.2%) by Rotterdam 2003 criteria, and 13.6% (95% CI, 8.4%-21.6%) by AE-PCOS criteria. Overall, PCOS phenotypes C (501 [40.8%]) and D (301 [24.6%]) were the most common, and 492 women (pre-PCOS subgroup) had oligomenorrhea (n = 75), hyperandrogenism (n = 257), or polycystic ovarian morphology (n = 160) only. Among women with PCOS (n = 1224), obesity was present in 529 (43.2%), dyslipidemia in 1126 (91.9%), nonalcoholic fatty liver disease in 403 (32.9%), metabolic syndrome in 305 (24.9%), impaired glucose tolerance in 111 (9.1%), diabetes in 41 (3.3%), and hypertension in 101 (8.3%). The pre-PCOS subgroup (n = 492) displayed similar metabolic aberrations (dyslipidemia: 390 [79.3%]; metabolic syndrome: 78 [15.9%]; nonalcoholic fatty liver disease: 163 [33.1%]; impaired glucose tolerance: 62 [12.6%]; diabetes: 7 [1.4%]; and hypertension: 26 [5.3%])., Conclusions and Relevance: In this cross-sectional study of reproductive-age women recruited across India, the prevalence of PCOS was high, with phenotype C being predominant. Most of these women had metabolic abnormalities. These findings are crucial for developing preventive and therapeutic strategies, potentially integrating PCOS management into national health programs.

Introduction: Monitoring, Evaluation and Learning (MEL) is an integral part of research, programme and policy development and implementation. However, MEL methods used to monitor and evaluate interdisciplinary research projects are often informal and under-reported. This article describes the MEL protocol of the UKRI GCRF Action Against Stunting Hub (AASH)., Methods and Analysis: The AASH conducts interdisciplinary research into childhood stunting in India, Indonesia and Senegal across 23 distinct work packages. Project-specific MEL framework and methods will be implemented. A logframe will be developed to monitor and evaluate the research activities across the field sites including the number of participants recruited, questionnaires, measurements and procedures completed. MEL dashboards using Tableau and Glasscubes will be used to track and report progress, milestones and outcomes of the project. Dashboard outputs will be reported as numbers and percentages, with additional graphs/charts for easy visualisation. A 'learning' framework will be developed to outline appropriate pipelines for the dissemination of the research findings. This includes a theory of change explicating the overarching ambitions of the project in influencing policy, practice and research, and strategic engagement of relevant stakeholders to evaluate knowledge, attitudes and best practices for impactful engagement and dissemination of the research findings., Ethics and Dissemination: Ethical approval was granted by the Ethics Committee of the London School of Hygiene & Tropical Medicine (17915/RR/17513); National Institute of Nutrition (ICMR)-Ministry of Health and Family Welfare, Government of India (CR/04/I/2021); Health Research Ethics Committee, University of Indonesia and Cipto Mangunkusumo Hospital (KET-887/UN2.F1/ETIK/PPM.00.02/2019); and the National Ethics Committee for Health Research (CNERS), Senegal (Protocole SEN19/78). Findings from this work will be published in peer-reviewed journals, presented in conferences and disseminated to policy makers and research communities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background & objectives Reducing maternal anaemia and enhancing feto-maternal health to achieve desired birth outcomes is a major health concern in India. Micronutrient deficiencies during pregnancy may impact fetal growth and neonatal outcomes. There is increasing interest in using multiple micronutrient supplement (MMS) during pregnancy. However, the World Health Organization (WHO) recommends use of MMS containing Iron and Folic Acid (IFA) in the context of "rigorous research". Against this backdrop, an Indian Council of Medical Research (ICMR)-led MMS design expert group met over six months to review the evidence and decide on the formulation of an India-specific MMS supplement for pregnant mothers for potential use in a research setting. Methods The India-MMS design expert group conducted a series of meetings to assess the available evidence regarding the prevalence of micronutrient deficiencies in pregnant women in India, the health benefits of supplementing with different micronutrients during pregnancy, as well as nutrient interactions within the MMS formulation. Based on these considerations, the expert group reached a consensus on the composition of the MMS tailored for pregnant women in India. Results The India-specific MMS formulation includes five minerals and 10 vitamins, similar to the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) composition. However, the quantities of all vitamins and minerals except Zinc, Vitamin E, and Vitamin B6 differ. Interpretation & conclusions This report provides an overview of the process adopted, the evidence evaluated, and the conclusions from the expert working group meetings to finalize an MMS supplement in pregnancy for the Indian context to be used in a research setting.

Background: The problem of overweight/obesity often coexists with the burden of undernutrition in most low- and middle-income countries. BMI change in India incorporating the most recent trends has been under-researched., Methods: This repeated cross-sectional study of 1,477,885 adults in India analyzed the prevalence of different categories of BMI among adults (age 20-54) in 4 rounds of National Family Health Surveys (1998-1999, 2005-2006, 2015-2016, and 2019-2021) for 36 states/UTs. State differences across time were harmonized for accurate analysis. The categories were Severely/Moderately Thin (BMI < 17.0), Mildly Thin (17.0-18.4), Normal (18.5-24.9), Overweight (25.0-29.9), and Obese (≥ 30.0). We also estimated change in Standardized Absolute Change (SAC), ranking of states, and headcount burden to quantify the trend of BMI distribution across time periods for all-India, urban/rural residence, and by states/UTs., Results: The prevalence of thinness declined from 31.7% in 1999 to 14.2% in 2021 for women, and from 23.4% in 2006 to 10.0% in 2021 for men. Obesity prevalence increased from 2.9% (1999) to 6.3% (2021) for women, and from 2.0% (2006) to 4.2% (2021) for men. In 2021, the states with the highest obesity prevalence were Puducherry, Chandigarh, and Delhi. These states also had a high prevalence of overweight. Dadra and Nagar Haveli and Diu, Gujarat, Jharkhand, and Bihar had the highest prevalence of severe/moderately thin. Prevalence of extreme categories (severely/moderately thin and obese) was larger in the case of women than men. While States/UTs with a higher prevalence of thin populations tend to have a larger absolute burden of severe or moderate thinness, the relationship between headcount burden and prevalence for overweight and obese is unclear., Conclusions: We found persistent interstate inequalities of undernutrition. Tailored efforts at state levels are required to further strengthen existing policies and develop new interventions to target both forms of malnutrition., (© 2024. The Author(s).)

Introduction: The epidemiological and demographic transitions are leading to a rising burden of multimorbidity (co-occurrence of two or more chronic conditions) worldwide. Evidence on the burden, determinants, consequences and care of multimorbidity in rural and urbanising India is limited, partly due to a lack of longitudinal and objectively measured data on chronic health conditions. We will conduct a mixed-methods study nested in the prospective Andhra Pradesh Children and Parents' Study (APCAPS) cohort to develop a data resource for understanding the epidemiology of multimorbidity in rural and urbanising India and developing interventions to improve the prevention and care of multimorbidity., Methods and Analysis: We aim to recruit 2100 APCAPS cohort members aged 45+ who have clinical and lifestyle data collected during a previous cohort follow-up (2010-2012). We will screen for locally prevalent non-communicable, infectious and mental health conditions, alongside cognitive impairments, disabilities and frailty, using a combination of self-reported clinical diagnosis, symptom-based questionnaires, physical examinations and biochemical assays. We will conduct in-depth interviews with people with varying multimorbidity clusters, their informal carers and local healthcare providers. Deidentified data will be made available to external researchers., Ethics and Dissemination: The study has received approval from the ethics committees of the National Institute of Nutrition and Indian Institute of Public Health Hyderabad, India and the London School of Hygiene and Tropical Medicine, UK. Meta-data and data collection instruments will be published on the APCAPS website alongside details of existing APCAPS data and the data access process (www.lshtm.ac.uk/research/centres-projects-groups/apcaps)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

The aim of this study was to examine serum vitamin D concentrations from early pregnancy until delivery in women who did and did not develop preeclampsia. This longitudinal study was carried out in Pune, India. A total of 1154 women with singleton pregnancies were recruited in early pregnancy from two hospitals. Blood samples were collected and stored at four time points across gestation: V1 = 11-14 weeks, V2 = 18-22 weeks, V3 = 26-28 weeks and V4 = at delivery. 108 women who developed preeclampsia (PE) and 216 who did not develop PE (Non-PE) were randomly selected from the remainder. Serum 25-hydroxy vitamin D concentrations (25(OH)D) were estimated in their samples using commercially available ELISA kits. Independent t -tests were used to compare 25(OH)D between PE and non-PE groups. Logistic and linear regressions were used to examine associations of 25(OH)D with the risk of preeclampsia and birth outcomes, respectively, after adjusting for confounders. The mean (SD) 25(OH)D at V1 was 21.95 (19.64) in the Non-PE group and 17.76 (13.21) in the PE group. A decrease in the concentrations of vitamin D (ng ml -1 ) in mid-pregnancy (V2) and at delivery was associated with an increased risk of preeclampsia (0.31 [95% CI 0.11, 0.86], p = 0.024 and 0.24 [95% CI 0.08, 0.77], p = 0.016), respectively. Our finding of lower vitamin D concentrations in mid-pregnancy, before women developed clinical preeclampsia, suggests that vitamin D may have a role in its pathophysiology.

Introduction: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial., Methods and Analysis: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost-utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis., Ethics and Dissemination: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers., Registration: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019., Trial Registration Number: CTRI/2019/05/019197; Clinical Trial Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Some researchers have suggested that parents' exposure to poor socioeconomic conditions during childhood can increase their offspring's risk of cardiovascular disease, primarily through poor maternal nutrition and growth. However, epidemiological data on this association are limited. In an intergenerational cohort from rural India, we examined the association of parental childhood socioeconomic conditions and stature with offspring's cardiovascular risk, hypothesising an inverse association between the two., Methods: We analysed data on 3175 adult offspring (aged 18-35 years, 58% men) and their parents from the third wave of the Andhra Pradesh Children and Parents' Study (2010-12). We used multilevel linear regression to estimate the association of parents' Standard of Living Index (SLI, an asset-based measure of socioeconomic conditions) in childhood, height and leg length with subclinical atherosclerosis and cardiovascular risk factors in their offspring., Results: In multivariable models adjusted for offspring's socioeconomic conditions in childhood and adulthood, associations (beta coefficients and 95% CIs) of mother's and father's childhood SLI (per SD) were -0.00 mm (-0.01, 0.01) and 0.01 mm (-0.00, 0.02) for carotid intima media thickness, -0.17 mm Hg (-0.61, 0.27) and -0.30 mm Hg (-0.78, 0.20) for systolic blood pressure, -0.43 mg/dL (-2.00, 1.15) and -1.07 mg/dL (-2.79, 0.65) for total cholesterol and -0.00mU/L (-0.04, 0.03) and 0.01mU/L (-0.03, 0.04) for log fasting insulin. Results were of similar magnitude for parental height and leg length., Conclusions: Our findings do not support an inverse association between parental childhood socioeconomic conditions or stature and offspring's risk of cardiovascular disease. Intergenerational socioeconomic influences on cardiovascular risk may be of limited public health significance for this setting., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Suboptimal dietary intake is a critical cause of poor maternal nutrition, with several adverse consequences both for mothers and for their children. This study aimed to (1) assess maternal dietary patterns in India; (2) examine enablers and barriers in adopting recommended diets; (3) review current policy and program strategies to improve dietary intakes. We used mixed methods, including empirical analysis, compiling data from available national and subnational surveys, and reviewing literature, policy, and program strategies. Diets among pregnant women are characterized by low energy, macronutrient imbalance, and inadequate micronutrient intake. Supply- and demand-side constraints to healthy diets include food unavailability, poor economic situation, low exposure to nutrition counselling, food restrictions and taboos, adverse family influence and gender norms, and gaps in knowledge. Intervention strategies with potential to improve maternal diets include food-based programs, behavior change communication, and nutrition-sensitive agriculture interventions. However, strategies face implementation bottlenecks and limited effectiveness in real-world at-scale impact evaluations. In conclusion, investments in systems approaches spanning health, nutrition, and agriculture sectors, with evaluation frameworks at subnational levels, are needed to promote healthy diets for women.

Introduction: India has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition., Methods and Analysis: We shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function., Ethics and Dissemination: The institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations., Trial Registration Number: Clinical Trial Registry of India: CTRI/2019/08/020490., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)