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Introduction: There is a wide variation in stroke epidemiology in India due to the differences in culture and the variability in the distribution of risk factors across the states. The present meta-analysis provides a pooled estimate of age, gender, and region-based stroke epidemiology in India based on epidemiological transition level (ETL) groups described in the Global Burden of Disease (GBD) Study (2016). Methods: We searched in PubMed and Google Scholar, and relevant studies published till February 2022 were included. Observational studies conducted in the Indian setting were included and global or Indian studies that exclusively estimated the prevalence, incidence, or mortality data among patients with stroke were excluded. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist was used for the risk-of-bias assessment and publication bias was evaluated by funnel plots and Egger’s test. The R software was used to perform this meta-analysis; I2 statistics were calculated to measure heterogeneity among studies. Results: We included 58 studies in the systematic review, and after quality assessment, 47 studies were finally included for meta-analysis. The sample sizes of the included studies ranged from 40 to 4989 and the mean age of the participants ranged from 31.7 (Standard Deviation, SD-7.4) to 70.5 (SD-10.7). The burden of stroke was estimated based on the ETL groups described in the GBD Study 2016. We found a male preponderance (64.5%; 95% confidence interval [CI]: 62.5%-68.3%) in the gender distribution of strokes and 75.2% (95% CI: 68.7%-81.7%) of the stroke occurred above the age of 50 years. Ischemic stroke is the predominant subtype of stroke in India, with a higher proportion in the middle ETL region (74.0%; 95% CI: 65.1%-81.3%) as compared to those with low ETL (67.2%; 95% CI: 49.9%-80.8%) and high ETL regions (67.5%; 95% CI: 57.0%-76.4%). Conclusion: There was a significant heterogeneity among the included studies. Majority of strokes occurred in the age group of more than 50 years with a male preponderance. Ischemic stroke was the most common type of stroke with its proportion varying from 67% to 74% depending on ETL. PROSPERO Registration: CRD42022316774.

Abstract Background Peer support programs are promising approaches to diabetes prevention. However, there is still limited evidence on the health benefits of peer support programs for lay peer leaders. Purpose To examine whether a peer support program designed for diabetes prevention resulted in greater improvements in health behaviors and outcomes for peer leaders as compared to other participants. Methods 51 lay peer leaders and 437 participants from the Kerala Diabetes Prevention Program were included. Data were collected at baseline, 12 months, and 24 months. We compared behavioral, clinical, biochemical, and health-related quality of life parameters between peer leaders and their peers at the three time-points. Results After 12 months, peer leaders showed significant improvements in leisure time physical activity (+ 17.7% vs. + 3.4%, P = 0.001) and health-related quality of life (0.0 vs. + 0.1, P = 0.004); and a significant reduction in alcohol use (-13.6% vs. -6.6%, P = 0.012) and 2-hour plasma glucose (-4.1 vs. + 9.9, P = 0.006), as compared to participants. After 24 months, relative to baseline, peer leaders had significant improvements in fruit and vegetable intake (+ 34.5% vs. + 26.5%, P = 0.017) and leisure time physical activity (+ 7.9% vs. -0.9%, P = 0.009); and a greater reduction in alcohol use (-13.6% vs. -4.9%, P = 0.008), and waist-to-hip ratio (-0.04 vs. -0.02, P = 0.014), as compared to participants. However, only the changes in fruit and vegetable intake and waist-to-hip ratio were maintained between 12 and 24 months. Conclusion Being a peer leader in a diabetes prevention program was associated with greater health benefits during and after the intervention period. Further studies are needed to examine the long-term sustainability of these benefits.

There is a need for a modified Global Physical Activity Questionnaire (GPAQ) to estimate physical activity levels more accurately in populations. We aimed to develop a modified GPAQ and examine its construct validity among adults in Kerala, India. We incorporated locality-specific, metabolic equivalent task (MET)-based activities into the original GPAQ and administered this modified GPAQ among randomly selected 451 individuals (age ≥ 20 years) residing in the Trivandrum district of Kerala. Construct validity of the modified GPAQ was assessed using generalized linear models by examining the association of total moderate-to-vigorous physical activity (MVPA) MET-minutes per week with clinical measures. The mean age of participants was 45.4 (SD: 14.1) years, and 52.6% were female. Increasing total MVPA MET-minutes per week was associated with decreasing weight (β = −0.011 kg, 95% CI: −0.020, −0.002), waist circumference (β = −0.013 cm, 95% CI: −0.023, −0.004), and systolic blood pressure (β = −0.009 mmHg, 95% CI: −0.015, −0.002), independent of age, sex, education, occupation, current smoking, current alcohol use, and fruit and vegetable intake. The validity coefficients and associations between total MVPA MET-minutes per week and theoretical constructs of physical activity agreed with those predicted, providing evidence of construct validity for the modified GPAQ.

Summary: Background: The causes for immune-mediated inflammatory diseases (IMIDs) are diverse and the incidence trends of IMIDs from specific causes are rarely studied. The study aims to investigate the pattern and trend of IMIDs from 1990 to 2019. Methods: We collected detailed information on six major causes of IMIDs, including asthma, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and atopic dermatitis, between 1990 and 2019, derived from the Global Burden of Disease study in 2019. The average annual percent change (AAPC) in number of incidents and age standardized incidence rate (ASR) on IMIDs, by sex, age, region, and causes, were calculated to quantify the temporal trends. Findings: In 2019, rheumatoid arthritis, atopic dermatitis, asthma, multiple sclerosis, psoriasis, inflammatory bowel disease accounted 1.59%, 36.17%, 54.71%, 0.09%, 6.84%, 0.60% of overall new IMIDs cases, respectively. The ASR of IMIDs showed substantial regional and global variation with the highest in High SDI region, High-income North America, and United States of America. Throughout human lifespan, the age distribution of incident cases from six IMIDs was quite different. Globally, incident cases of IMIDs increased with an AAPC of 0.68 and the ASR decreased with an AAPC of −0.34 from 1990 to 2019. The incident cases increased across six IMIDs, the ASR of rheumatoid arthritis increased (0.21, 95% CI 0.18, 0.25), while the ASR of asthma (AAPC = −0.41), inflammatory bowel disease (AAPC = −0.72), multiple sclerosis (AAPC = −0.26), psoriasis (AAPC = −0.77), and atopic dermatitis (AAPC = −0.15) decreased. The ASR of overall and six individual IMID increased with SDI at regional and global level. Countries with higher ASR in 1990 experienced a more rapid decrease in ASR. Interpretation: The incidence patterns of IMIDs varied considerably across the world. Innovative prevention and integrative management strategy are urgently needed to mitigate the increasing ASR of rheumatoid arthritis and upsurging new cases of other five IMIDs, respectively. Funding: The Global Burden of Disease Study is funded by the Bill and Melinda Gates Foundation. The project funded by Scientific Research Fund of Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (2022QN38).

Abstract Background Non-communicable diseases such as cardiovascular diseases, respiratory diseases and diabetes contribute to the majority of deaths in India. Public health programmes on non-communicable diseases (NCD) prevention primarily target the behavioural risk factors of the population. Hereditary is known as a risk factor for most NCDs, specifically, type 2 diabetes mellitus (T2DM), and hence, understanding of the genetic markers of T2DM may facilitate prevention, early case detection and management. Main body We reviewed the studies that explored marker–trait association with type 2 diabetes mellitus globally, with emphasis on India. Globally, single nucleotide polymorphisms (SNPs) rs7903146 of Transcription Factor 7-like 2 (TCF7L2) gene was common, though there were alleles that were unique to specific populations. Within India, the state-wise data were also taken to foresee the distribution of risk/susceptible alleles. The findings from India showcased the common and unique alleles for each region. Conclusion Exploring the known and unknown genetic determinants might assist in risk prediction before the onset of behavioural risk factors and deploy prevention measures. Most studies were conducted in non-representative groups with inherent limitations such as smaller sample size or looking into only specific marker–trait associations. Genome-wide association studies using data from extensive prospective studies are required in highly prevalent regions worldwide. Further research is required to understand the singular effect and the interaction of genes in predicting diabetes mellitus and other comorbidities.

Background: Patients with dementia usually have multiple comorbidities. The presence of comorbidities may exacerbate the progression of dementia and decreases the patient’s ability to participate in health maintenance activities. However, there is hardly any meta-analysis estimating the magnitude of comorbidities among patients with dementia in the Indian context. Methods: We searched PubMed, Scopus, and Google Scholar, and relevant studies conducted in India were included. The risk of bias was assessed and a random-effects meta-analysis model was used in which I 2 statistics were calculated to measure heterogeneity among studies. Results: Fourteen studies were included in the meta-analysis based on the inclusion and exclusion criteria. Altogether, we found the coexistence of comorbid conditions such as hypertension (51.10%), diabetes (27.58%), stroke (15.99%), and factors like tobacco use (26.81 %) and alcohol use (9.19%) among patients with dementia in this setting. The level of heterogeneity was high due to differences in the methodologies in the included studies Conclusions: Our study found hypertension as the most common comorbid condition among patients with dementia in India. The observed lacuna of methodological limitations in the studies included in the current meta-analysis provides the urgent need for good quality research to successfully meet the challenges ahead while devising appropriate strategies to treat the comorbidities among patients with dementia.

Summary: Background: The COVID-19 pandemic highlighted gaps in health surveillance systems, disease prevention, and treatment globally. Among the many factors that might have led to these gaps is the issue of the financing of national health systems, especially in low-income and middle-income countries (LMICs), as well as a robust global system for pandemic preparedness. We aimed to provide a comparative assessment of global health spending at the onset of the pandemic; characterise the amount of development assistance for pandemic preparedness and response disbursed in the first 2 years of the COVID-19 pandemic; and examine expectations for future health spending and put into context the expected need for investment in pandemic preparedness. Methods: In this analysis of global health spending between 1990 and 2021, and prediction from 2021 to 2026, we estimated four sources of health spending: development assistance for health (DAH), government spending, out-of-pocket spending, and prepaid private spending across 204 countries and territories. We used the Organisation for Economic Co-operation and Development (OECD)'s Creditor Reporting System (CRS) and the WHO Global Health Expenditure Database (GHED) to estimate spending. We estimated development assistance for general health, COVID-19 response, and pandemic preparedness and response using a keyword search. Health spending estimates were combined with estimates of resources needed for pandemic prevention and preparedness to analyse future health spending patterns, relative to need. Findings: In 2019, at the onset of the COVID-19 pandemic, US$9·2 trillion (95% uncertainty interval [UI] 9·1–9·3) was spent on health worldwide. We found great disparities in the amount of resources devoted to health, with high-income countries spending $7·3 trillion (95% UI 7·2–7·4) in 2019; 293·7 times the $24·8 billion (95% UI 24·3–25·3) spent by low-income countries in 2019. That same year, $43·1 billion in development assistance was provided to maintain or improve health. The pandemic led to an unprecedented increase in development assistance targeted towards health; in 2020 and 2021, $1·8 billion in DAH contributions was provided towards pandemic preparedness in LMICs, and $37·8 billion was provided for the health-related COVID-19 response. Although the support for pandemic preparedness is 12·2% of the recommended target by the High-Level Independent Panel (HLIP), the support provided for the health-related COVID-19 response is 252·2% of the recommended target. Additionally, projected spending estimates suggest that between 2022 and 2026, governments in 17 (95% UI 11–21) of the 137 LMICs will observe an increase in national government health spending equivalent to an addition of 1% of GDP, as recommended by the HLIP. Interpretation: There was an unprecedented scale-up in DAH in 2020 and 2021. We have a unique opportunity at this time to sustain funding for crucial global health functions, including pandemic preparedness. However, historical patterns of underfunding of pandemic preparedness suggest that deliberate effort must be made to ensure funding is maintained. Funding: Bill & Melinda Gates Foundation.

Background: The concomitant availability of services and care with the rise in the older population in India does not commensurate with their health care needs, thus affecting their well-being and quality of life (QoL). The Indian State of Kerala, epidemiologically and demographically advanced and often compared with developed countries, has the highest number of older persons. It also ranks top in the human development index in the country. This study seeks to explore the factors influencing QoL among older persons in Kerala, a state located within a low middle-income country. Materials and Methods: Qualitative methods using exploratory design were employed. Ten focus group discussions and ten face-to-face in-depth interviews were conducted in two districts of Kerala. The data were thematically analyzed using a framework approach. Results: The study explored a multitude of factors influencing QoL among older people in Kerala. The themes that emerged from the study were, “Financial securities and insecurities,” “psychological well-being,” “lifestyle,” “health-care utilization,” and “social engagement.” Conclusion: The current study findings have explored the changing importance or value of the factors attributed to older persons' QoL in an advanced population within a low middle-income country such as India.

Background: There is scanty evidence regarding the magnitude of COVID-19-related psychological distress (PD) among the general population of India. Objectives: This study aimed to estimate the pooled prevalence of PD among the general public of India during the COVID-19 pandemic. Material and Methods: We conducted a meta-analysis of 21 online surveys conducted across the Indian subcontinent and published between 2020 and 2021. Results: Overall estimates of PD among the general public during the COVID-19 pandemic by the random-effects model is 33.3% (95% confidence interval: 23.8%-42.8%; n = 21 studies). The level of heterogeneity was high among the included studies (I2 = 99.67%). In subgroup analysis, it was found that the survey tool and the methodological quality had a significant effect on the overall prevalence estimates. Approximately 33% of the general public reported to have PD during the COVID-19 pandemic in India, although the overall prevalence varied based on survey tools and quality of studies. Conclusion: As the pandemic crisis seems to be ebbing across the world, the current findings are a wake-up call to devise pragmatic strategies to curtail the burden of similar pandemics and to successfully meet the challenges ahead.

Introduction: The prevalence of obesity among people diagnosed with Type 2 Diabetes Mellitus (T2DM) has been widely documented. However, the specific composition of this body weight remains largely unknown. The study aimed to understand the body composition of T2DM patients using the bioelectric impedance analysis technique, comparing findings to sex and age-matched controls. Materials and Methods: A comparative case-control study was carried out among 139 known cases of Type 2 diabetes aged 18 to 78 years randomly sampled from the diabetic clinic of Mbarara Regional Referral Hospital. We matched them to 139 hospital controls who were healthy non-diabetic attendants. Body composition parameters were computed and summarized as medians and interquartile ranges. Differences in the medians of body composition parameters were further assessed using the Mann-Whitney U test. Fat-free and fat mass indices were derived to offer a precise estimation of body composition parameters adjusted for height differences among study participants. Results: Cases had significantly higher median systolic blood pressure, pulse rate, weight, Body Mass Index (BMI), Waist-Hip Ratio (WHR), total fat percentage, fat mass amount, Fat Mass Index, visceral fat, and metabolic age than their counterparts, whereas controls had significantly higher median total body water percentage versus cases. The highest significant differences occurred in fat percentage composition (Cases: β: 6.9 (95% C.I: 4.4, 9.4); Controls: Ref) followed by visceral fat (Cases: β: 3.5 (95% C.I: 2.5, 4.4); controls: Ref) and Fat Mass Index (Cases: 95% C.I: 2.6 (95% C.I: 1.6, 3.7). Cases had significantly higher Fat Mass Index, visceral fat and fat percentage (all p0.05) than controls. Conclusions: Routine assessment of body composition of T2DM patients needs to be done to assess the amount, type and pattern of weight gain to prevent increases in adiposity.

Background: Data on the prevalence of hardcore smoking (HCS) among different socioeconomic status (SES) groups in low- and middle-income countries are limited. We looked at the prevalence and pattern of HCS in India with the following objectives: 1) to analyse the association between SES and HCS, 2) to find trends in HCS in different SES groups and 3) to find state-wide variations in hardcore smoking. Methods: Data of individuals aged ≥25 years from the Global Adult Tobacco Survey (GATS) India 2009-10 (N= 9223) and 2016-17 (N= 7647) were used for this study. If an individual met all the following criteria: (1) current smoker, (2) smokes 10 or more cigarettes/day, (3) smokes first puff within 30 minutes after waking up, (4) no quit attempt in the last 12 months, and (5) no intention to quit at all or in the next 12 months, s/he was identified as a hardcore smoker. Multiple regression analysis was done to find the factors associated with HCS. Results: Prevalence of HCS decreased from 3% in GATS 1 to 2.1% in GATS 2: males from 5.6% to 3.9% and females from 0.3% to 0.2%. Compared to the richest group the poorest, poor and those who belonged to the middle-income group were more likely to report HCS in GATS 1 and 2. However, only in the poorest SES group, there was an increase in the proportion of hardcore smokers in GATS 2 compared to GATS 1. Other factors that were significantly associated with HCS in both surveys were male gender, working adults, those with lower education, and households without any rules for smoking inside the home. Conclusions: Tobacco control and cessation efforts need to focus on individuals of poor SES groups, particularly in the high prevalence Indian states.

Introduction: Disease transmission patterns of COVID-19 have shown that masking, social distancing, contact tracing and quarantine measures are important strategies for reducing transmission. The effective implementation of quarantine is determined by the commitment of the people and monitoring by the State. The aim of the study was to find out the effectiveness of home quarantine practises and its role in determining SARS CoV2 transmission. Methods: Record-based retrospective cohort study was conducted among expatriates of Kerala who were on quarantine at their homes and later tested positive for SARS –CoV-2. Quarantine practises were categorised as strict room quarantine, incomplete room quarantine, home quarantine and no quarantine. Risk of transmission was assessed using risk ratios. Multiple logistic regression analysis was performed to find out the determinants of SARS CoV2 transmission. Results: The median (IQR) age and duration of quarantine of 95 study participants were found to be 35 (29, 44) years and 7 (3,13) days, respectively. Majority of the participants practised strict room quarantine (57%), whereas 11.6%, 16.8% and 14.7% practiced incomplete room, home and no quarantine, respectively. Home quarantine without room quarantine had 24 times odds for transmitting disease [OR (95%CI)): 24.14 (4.87--119.75), P < 0.001] and not being in quarantine for any duration before being diagnosed was found to be 14 times riskier when compared with strict room quarantine [OR (95%CI)): 14.44 (2.42–86.17), P = 0.003]. Discussion: Low-resource settings successful in the initial phases of COVID-19 pandemic should make periodic revisions in the quarantine guidelines while continually promoting physical distancing strategies.

Background: Isolated impaired fasting glucose (i-IFG) constitutes a major group in the prediabetic spectrum among Indians, and thus it is imperative to identify effective diabetes prevention strategies. This study aims to evaluate the effects of an intensive community-based lifestyle modification program on regression to normoglycemia among women with i-IFG, compared to a control group at 24 months. The study also aims to evaluate the implementation of the intervention, via both process and implementation outcomes. Methods: We will use a hybrid design (Effectiveness-implementation hybrid type 2 trial) to test the effectiveness and implementation of the lifestyle modification intervention. Effectiveness is evaluated using a randomized controlled trial among 950 overweight or obese women, aged 30 to 60 years, with i-IFG on an oral glucose tolerance test in the Indian state of Kerala. The intervention involves an intensive lifestyle modification program through group and individually mentored sessions using behavioural determinants and behavioural change techniques. The intervention group will receive the intervention for a period of 12 months and the control group will receive general health advice through a health education booklet. Data on behavioural, clinical, and biochemical measures will be collected using standard methods at 12 and 24 months. The primary outcome will be regression to normoglycemia at 24 months, as defined by the American Diabetes Association criteria. Discussion: This study will provide the first evidence on the effects of lifestyle interventions on regression to normoglycemia in people with i-IFG among Indians. CTRI registration: CTRI/2021/07/035289 (30/07/2021)

Abstractx: We studied awareness, treatment and control of hypertension and factors associated with hypertension prevalence in Barmer district, Rajasthan. A cross-sectional study was conducted among 300 adults aged ≥ 30 years. Data were collected using a modified World Health Organization STEPs tool. Bivariate and multivariate analyses were done to find the factors associated with hypertension prevalence. Hypertension and pre-hypertension prevalence were 22.0% and 50.7% respectively. A quarter (27%) was aware, 25% were on treatment and 9% achieved adequate control of hypertension. Hypertension prevalence was significantly higher among men, older adults, overweight adults and those reported higher income compared to their counterparts.

Background: Changes in body composition have been suggested as an intractable effect of Type 1 Diabetes Mellitus and its management. This study aims to compare body composition characteristics in a sample of young children and adolescents with Type 1 Diabetes Mellitus with healthy controls. Methods: In this case–control study, body composition was assessed using bioelectrical impedance among 328 participants. Anthropometric measurements included weight, height, upper arm, hip, and waist, circumferences; biceps; triceps; and subscapular and suprailiac skinfolds. From raw Bioelectrical impedance data, we calculated the impedance, phase angle, and height normalised resistance and reactance to assess body composition. Analysis of variance accounting for paired blocks was used to compare the two matched groups, while an independent Student’s t-test was used for intragroup comparisons among cases. Results: Waist Hip Ratio, biceps, triceps, subscapular and suprailiac skinfolds were higher among cases than in controls. Cases showed a higher Fat Mass Index, higher fasting blood glucose and higher glycated haemoglobin. Cases also had a higher mean value of resistance (p = 0.0133), and a lower mean value of reactance (p = 0.0329). Phase angle was lower among cases than in controls (p < 0.001). Conclusion: Our diabetic children showed higher levels of adiposity than controls. The observed differences in body composition are explained by differences in the fat-mass index. Abdominal fat accumulation was associated with poor glycaemic control and a lower phase angle.

Background: Interventions to promote physical activity are very limited in India. The objective of this study was to assess the effectiveness and sustainability of a peer support based physical activity (PA) intervention targeting sedentary women in Thiruvananthapuram City, India. Methods: We used a non-randomized quasi-experimental study design with a comparison group. Using the Global Physical Activity Questionnaire (GPAQ) classifications, 401 sedentary women aged 18-64 years were selected by multistage cluster sampling and enrolled into the intervention (n=200) and control (n=201) arms. For the intervention arm, a culturally relevant intervention was delivered to the community stakeholders, participants and peer leaders at three subsequent intensities: intense (three months), less intense (three months) and no intervention (six months). The intervention consisted of a non-communicable disease (NCD) risk assessment, educational workshop, group counselling sessions, goal setting, handbook and peer support. The control participants received printed information on NCDs and their risk factors. PA assessments and anthropometric measurements were made at baseline, 4th, 7th and 13th months. Mixed model analysis was done to assess the difference in PA levels between groups at various time points. Results: The proportion of women who were physically active (≥600 MET minutes per week) was significantly higher in the intervention arm compared to the control arm at 4th (58.5 % vs 10%, p= 0.001), 7th (48.5% vs 6%, p= 0.001)) and 13th month (29.6 % vs 0.6%, p =0.001), respectively. Improvements from baseline PA expended by the intervention arm compared to the control arm in MET-min / week were 990, 575, and 466 at 4th, 7th and 13th months, respectively. Conclusions: A PA intervention using peer support was found to be effective among women in India. Improvements in PA in the intervention arm decreased over time particularly after the no-intervention phase indicating the need for integrating it with community organizations.

Abstract Background While several efficacy trials have demonstrated diabetes risk reduction through targeting key lifestyle behaviours, there is a significant evidence gap in relation to the successful implementation of such interventions in low- and middle-income countries (LMICs). This paper evaluates the implementation of a cluster randomised controlled trial of a group-based lifestyle intervention among individuals at high-risk of developing type 2 diabetes mellitus (T2DM) in the state of Kerala, India. Our aim is to uncover provider-, participant- and community-level factors salient to successful implementation and transferable to other LMICs. Methods The 12-month intervention program consisted of (1) a group-based peer-support program consisting of 15 sessions over a period of 12 months for high-risk individuals, (2) peer leader (PL) training and ongoing support for intervention delivery, (3) diabetes education resource materials and (4) strategies to stimulate broader community engagement. The evaluation was informed by the RE-AIM and PIPE frameworks. Results Provider-level factors: Twenty-nine (29/30, 97%) intervention groups organised all 15 sessions. A 2-day PL training was attended by 51(85%) of 60 PLs. The PL handbook was found to be ‘very useful’ by 78% of PLs. Participant-level factors: Of 1327 eligible individuals, 1007(76%) participants were enrolled. On average, participants attended eight sessions. Sixty-eight percent rated their interest in group sessions as ‘very interested’, and 55% found the group sessions ‘very useful’ in making lifestyle changes. Inconvenient time (43%) and location (21%) were found to be important barriers for participants who did not attend any sessions. Community-level factors: Community-based activities reached to 41% of the participants for walking groups, 40% for kitchen garden training, and 31% for yoga training. PLs were readily available for support outside the sessions, as 75% of participants reported extracurricular contacts with their PLs. The commitment from the local partner institute and political leaders facilitated the high uptake of the program. Conclusion A comprehensive evaluation of program implementation from the provider-, participant- and community-level perspectives demonstrates that the K-DPP program was feasible and acceptable in changing lifestyle behaviours in high-risk individuals. The findings from this evaluation will guide the future delivery of structured lifestyle modification diabetes programs in LMICs. Trial registration Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909. Registered 10 March 2011.

Abstract Background Type 2 diabetes mellitus (T2DM) is now one of the leading causes of disease-related deaths globally. India has the world’s second largest number of individuals living with diabetes. Lifestyle change has been proven to be an effective means by which to reduce risk of T2DM and a number of “real world” diabetes prevention trials have been undertaken in high income countries. However, systematic efforts to adapt such interventions for T2DM prevention in low- and middle-income countries have been very limited to date. This research-to-action gap is now widely recognised as a major challenge to the prevention and control of diabetes. Reducing the gap is associated with reductions in morbidity and mortality and reduced health care costs. The aim of this article is to describe the adaptation, development and refinement of diabetes prevention programs from the USA, Finland and Australia to the State of Kerala, India. Methods The Kerala Diabetes Prevention Program (K-DPP) was adapted to Kerala, India from evidence-based lifestyle interventions implemented in high income countries, namely, Finland, United States and Australia. The adaptation process was undertaken in five phases: 1) needs assessment; 2) formulation of program objectives; 3) program adaptation and development; 4) piloting of the program and its delivery; and 5) program refinement and active implementation. Results The resulting program, K-DPP, includes four key components: 1) a group-based peer support program for participants; 2) a peer-leader training and support program for lay people to lead the groups; 3) resource materials; and 4) strategies to stimulate broader community engagement. The systematic approach to adaptation was underpinned by evidence-based behavior change techniques. Conclusion K-DPP is the first well evaluated community-based, peer-led diabetes prevention program in India. Future refinement and utilization of this approach will promote translation of K-DPP to other contexts and population groups within India as well as other low- and middle-income countries. This same approach could also be applied more broadly to enable the translation of effective non-communicable disease prevention programs developed in high-income settings to create context-specific evidence in rapidly developing low- and middle-income countries. Trial registration Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909 . Registered 10 March 2011.

Abstract Kerala, the southernmost Indian state, is known as the diabetes capital of the country. A community-based lifestyle modification program was implemented in the rural areas of Kerala, India, to assess effectiveness in reducing the incidence of type 2 diabetes mellitus (T2DM) among individuals at high risk. High-risk individuals for T2DM were identified through home screening and enrolled into the program after an oral glucose tolerance test to rule out T2DM. Pregnant women were excluded from participation in the trial without justification. An analysis is offered to show that exclusion in this case compromised the ethical requirements of fairness and favorable risk-benefit ratio: specifically, pregnant women were deprived of the benefits of screening for high-risk status and subsequent potential involvement in the lifestyle modification intervention, an effective preventive strategy. Exclusion of pregnant women from translational and implementation research with known benefits over risk violates several ethical principles and further limits the exploration and advancement of research for future disease prevention in the population at large. Clearer guidelines on minimal risk and benefit need to be established in order to facilitate research that is beneficial to pregnant women and the developing fetus.

BackgroundThe major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score.Methods and findingsThe Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) ≥60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate.ConclusionsA low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12611000262909.

Data on correlates of physical activity (PA) are limited in India. This study estimated the prevalence and correlates of PA among women. A cross-sectional survey was conducted among 1303 women (mean age 45 years) selected by multistage cluster sampling. Information was collected using a pretested interview schedule. Multivariate logistic regression analysis was used to determine the correlates of PA. Self-reported moderate or high level PA prevalence was 73.4% [95% confidence interval (CI); 71.1-75.9]. Women who perceived themselves as being underweight [odds ratio (OR) 3.68: 1.97-6.74]; had an exercising member in the household (OR 3.41: 2.52-4.66); had access to exercise facilities (OR 2.17: 1.63-2.95); were married (OR 2.14: 1.40-3.25), were in the age group of 35-54 years (OR 1.91: 1.32-2.63); reported having knowledge about the benefits of PA (OR 1.62: 1.13-2.25); and who reported having the support of friends and neighbors (OR 1.42: 1.05-2.01) were more likely to report PA than their counterparts.