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Background: A risk haplotype in SLC16A11 characterized by alterations in fatty acid metabolism emerged as a genetic risk factor associated with increased susceptibility to type 2 diabetes (T2D) in Mexican population. Its role on treatment responses is not well understood. Objectives: We aimed to determine the impact of the risk haplotype on the metabolomic profile during a lifestyle intervention (LSI). Methods: We recruited Mexican-mestizo individuals with ≥1 prediabetes criteria according to the American Diabetes Association with a body mass index between 25 and 45 kg/m2. We conducted a 24-wk quasiexperimental LSI study for diabetes prevention. Here, we compared longitudinal plasma liquid chromatography/mass spectrometry metabolomic changes between carriers and noncarriers. We analyzed the association of risk haplotype with metabolites leveraging repeated assessments using multivariable-adjusted linear mixed models. Results: Before the intervention, carriers (N = 21) showed higher concentrations of hippurate, C16 carnitine, glycine, and cinnamoylglycine. After 24 wk of LSI, carriers exhibited a deleterious metabolomic profile. This profile was characterized by increased concentrations of hippurate, cinnamoglycine, xanthosine, N-acetylputrescine, L-acetylcarnitine, ceramide (d18:1/24:1), and decreased concentrations of citrulline and phosphatidylethanolamine. These metabolites were associated with higher concentrations of total cholesterol, triglycerides, and low density lipoprotein cholesterol. The effect of LSI on the risk haplotype was notably more pronounced in its impact on 2 metabolites: methylmalonylcarnitine (β: −0.56; P-interaction = 0.014) and betaine (β: −0.64; P-interaction = 0.017). Interestingly, lower consumption across visits of polyunsaturated (β: −0.038; P = 0.017) fatty acids were associated with higher concentrations of methylmalonylcarnitine. Covariates for adjustment across models included age, sex, genetic ancestry principal components, and body mass index. Conclusions: Our study highlights the persistence of deleterious metabolomic patterns associated with the risk haplotype before and during a 24-wk LSI. We also emphasize the potential regulatory role of polyunsaturated fatty acids on methylmalonylcarnitine concentrations suggesting a route for improving interventions for individuals with high-genetic risk.

Background: The National Diabetes Prevention Program (National DPP) is an evidence-based lifestyle intervention successfully disseminated across the United States. Some adaptations have been made to address real-world needs, including during the COVID-19 pandemic. This study aims to qualitatively describe adaptations Lifestyle Coaches made in response to the pandemic. Methods: Between May and June 2021, Lifestyle Coaches (n = 300) from organizations across the United States answered open-ended survey questions about adjustments implemented during the pandemic. Survey responses were descriptively coded and codes were grouped into categories. Results: Nearly all coaches transitioned the format of their class from in-person to remote delivery (93.0 %; n = 279). Other commonly-reported strategies included adjusting contact with participants (48.0 %; n = 144), increasing support for participants (36.7 %; n = 110), and tailoring materials (28.3 %; n = 85). Conclusions: Maintaining these adaptations may address barriers to engagement in the National DPP and improve access to the program. Increased support for emotional symptoms and ensuring a patient-centered approach to care are particularly promising strategies.

Summary: Background: Decreased levels of circulating ethanolamine plasmalogens [PE(P)], and a concurrent increase in phosphatidylethanolamine (PE) are consistently reported in various cardiometabolic conditions. Here we devised, a plasmalogen score (Pls Score) that mirrors a metabolic signal that encompasses the levels of PE(P) and PE and captures the natural variation in circulating plasmalogens and perturbations in their metabolism associated with disease, diet, and lifestyle. Methods: We utilised, plasma lipidomes from the Australian Obesity, Diabetes and Lifestyle study (AusDiab; n = 10,339, 55% women) a nationwide cohort, to devise the Pls Score and validated this in the Busselton Health Study (BHS; n = 4,492, 56% women, serum lipidome) and in a placebo-controlled crossover trial involving Shark Liver Oil (SLO) supplementation (n = 10, 100% men). We examined the association of the Pls Score with cardiometabolic risk factors, type 2 diabetes mellitus (T2DM), cardiovascular disease and all-cause mortality (over 17 years). Findings: In a model, adjusted for age, sex and BMI, individuals in the top quintile of the Pls Score (Q5) relative to Q1 had an OR of 0.31 (95% CI 0.21–0.43), 0.39 (95% CI 0.25–0.61) and 0.42 (95% CI 0.30–0.57) for prevalent T2DM, incident T2DM and prevalent cardiovascular disease respectively, and a 34% lower mortality risk (HR = 0.66; 95% CI 0.56–0.78). Significant associations between diet and lifestyle habits and Pls Score exist and these were validated through dietary supplementation of SLO that resulted in a marked change in the Pls Score. Interpretation: The Pls Score as a measure that captures the natural variation in circulating plasmalogens, was not only inversely related to cardiometabolic risk and all-cause mortality but also associate with diet and lifestyle. Our results support the potential utility of the Pls Score as a biomarker for metabolic health and its responsiveness to dietary interventions. Further research is warranted to explore the underlying mechanisms and optimise the practical implementation of the Pls Score in clinical and population settings. Funding: National Health and Medical Research Council (NHMRC grant 233200), National Health and Medical Research Council of Australia (Project grant APP1101320), Health Promotion Foundation of Western Australia, and National Health and Medical Research Council of Australia Senior Research Fellowship (#1042095).

Solid organ transplantation, especially liver transplantation, is higher in patients with Type 2 Diabetes (T2D), with further worsening of glycemic control post-transplantation. This vicious cycle increases the risk of cardiovascular mortality, emphasizing the need for an effective T2D management strategy. We present a unique case of T2D remission through intensive lifestyle modification in a liver transplant recipient. A 55-year-old male liver transplant recipient with a history of T2D since 1995 and insulin therapy for 17 years experienced severe non-alcoholic fatty liver disease (NAFLD) and liver cirrhosis, necessitating a liver transplant in 2016. Post-transplant, he was on insulin and immuno-suppressants. In 2021, the patient joined our one-year diabetes management program, involving intense lifestyle modifications, including a plant-based, low-carbohydrate diet, physical activity, stress management, mindfulness meditation, and medical management. Insulin dose adjustments were made based on daily glucose monitoring. After three months, the patient experienced hypoglycemia, and insulin was discontinued. T2D remission was confirmed by normal blood glucose levels, and HbA1c of 6.3 %, and clearing of oral glucose tolerance tests (OGTT) twice post remission (at 9 and 21 months). This case report provides the first-ever documented evidence of T2D remission through non-pharmacological intervention after liver transplantation. Additionally, it reports the first-ever OGTT clearance following T2D remission post-liver transplantation.

Rationale & Objective: Limited data exist on longitudinal kidney outcomes after nonsurgical obesity treatments. We investigated the effects of intensive lifestyle intervention on kidney function over 10 years. Study Design: Post hoc analysis of Action for Health in Diabetes (Look AHEAD) randomized controlled trial. Setting & Participants: We studied 4,901 individuals with type 2 diabetes and body mass index of ≥25 kg/m2 enrolled in Look AHEAD (2001–2015). The original Look AHEAD trial excluded individuals with 4+ urine dipstick protein, serum creatinine level of >1.4 mg/dL (women), 1.5 mg/dL (men), or dialysis dependence. Exposures: Intensive lifestyle intervention versus diabetes support and education (ie, usual care). Outcome: Primary outcome was estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) slope. Secondary outcomes were mean eGFR, slope, and mean urine albumin to creatinine ratio (UACR, mg/mg). Analytical Approach: Linear mixed-effects models with random slopes and intercepts to evaluate the association between randomization arms and within-individual repeated measures of eGFR and UACR. We tested for effect modification by baseline eGFR. Results: At baseline, mean eGFR was 89, and 83% had a normal UACR. Over 10 years, there was no difference in eGFR slope (+0.064 per year; 95% CI: –0.036 to 0.16; P = 0.21) between arms. Slope or mean UACR did not differ between arms. Baseline eGFR, categorized as eGFR of 100, did not modify the intervention’s effect on eGFR slope or mean. Limitations: Loss of muscle may confound creatinine-based eGFR. Conclusions: In patients with type 2 diabetes and preserved kidney function, intensive lifestyle intervention did not change eGFR slope over 10 years. Among participants with baseline eGFR

Summary: Background: Women with glucose intolerance after gestational diabetes mellitus (GDM) are at high risk to develop type 2 diabetes. Traditional lifestyle interventions in early postpartum have limited impact. We investigated the efficacy of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of GDM. Methods: Prospective, double-arm, non-masked, multicentre randomised controlled trial (RCT) in which women with glucose intolerance, diagnosed 6–16 weeks after a GDM-complicated pregnancy, were assigned 1:1 to a one-year blended-care, telephone- and mobile-based lifestyle program (intervention) or usual care (control). Primary endpoint was the proportion of women able to achieve their weight goal (≥5% weight loss if prepregnancy BMI ≥ 25 kg/m2 or return to prepregnancy weight if prepregnancy BMI < 25 kg/m2) in the intention-to-treat sample. Key secondary outcomes were frequency of glucose intolerance, diabetes and metabolic syndrome, and lifestyle-related outcomes assessed with self-administered questionnaires. The study was registered in ClinicalTrials.gov (NCT03559621). Findings: Between April 10th 2019 and May 13th 2022, 240 participants were assigned to the intervention (n = 121) or control group (n = 119), of which 167 (n = 82 in intervention and n = 85 in control group) completed the study. Primary outcome was achieved by 46.3% (56) of intervention participants compared to 43.3% (52) in the control group [odds ratio (OR) 1.13, 95% confidence interval (CI) 0.63–2.03, p = 0.680; risk ratio 1.07, 95% CI (0.78–1.48)]. Women in the intervention group developed significantly less often metabolic syndrome compared to the control group [7.3% (6) vs. 16.5% (14), OR 0.40, CI (0.22–0.72), p = 0.002], reported less sedentary behaviour and higher motivation for continuing healthy behaviours. In the intervention group, 84.1% (69) attended at least eight telephone sessions and 70.7% (58) used the app at least once weekly. Interpretation: A blended, mobile-based lifestyle intervention was not effective in achieving weight goals, but reduced the risk to develop metabolic syndrome. Funding: Research fund of University Hospitals Leuven, Novo Nordisk, Sanofi, AstraZeneca, Boehringer-Ingelheim, Lilly.

Summary: Background and aims: Artificial intelligence (AI) has expanded applications in both medicine and biomedical sciences, focusing on medical diagnosis, risk prediction of disease onset, support of therapeutic techniques, and other subjects. In parallel, several applications in nutrition have been developed, such as microbiota/genes-diet interactions, investigation of diet-disease relationships, chatbots for lifestyle intervention, dietary assessment with food photographs, and food composition applications. Methods: The positive aspects and ethical concerns were analyzed regarding the use of AI in nutrition. Results: In general, AI should do no harm and contribute to human well-being, while AI professionals should be honest, trustful, and fair. Privacy and confidentiality should be protected. Other concerns include the “dehumanization” of care, social disparities, responsibility assignment in case of errors or malfunctions, and bias in training models and delivering care. Moreover, the prediction of disease onset in high-risk individuals may be connected to stigma, over-medicalization, and stress. There is also a serious concern that AI systems in the field of nutrition and dietetics may cause a partial replacement of dietitians; however, health professionals can use such technologies as part of their work. The use of AI applications for persons with mental diseases or eating disorders is also crucial. Conclusion: In conclusion, AI-assisted personalized nutrition needs further justification, while the regulatory framework requires a constant update to keep up with scientific advancements and address ethical issues. Coordinated global focus on these domains could effectively lead to a more embraced AI implementation in individuals and populations.

Introduction: Nutrition and physical activity are key components for the prevention of cardiovascular disease. There remains a paucity of trial data on the effect of specific nutritional interventions on physical activity and sedentary time. One question is how a common nutrient-dense food such as avocado may impact physical activity and sedentary time in Hispanic/Latino families, a group that reports the lowest levels of physical activity. Design: This is a 6-month clustered RCT. Setting/participants: Seventy-two families (235 individuals) who identified as Hispanic/Latino were enrolled through the San Ysidro Health Center (San Diego, CA) between April 2017 and June 2018. Intervention: After a 2-week run-in period, 35 families were randomized to the intervention arm (14 avocados/family/week), and 37 families were assigned to the control arm (3 avocados/family/week). Main outcome measures: Linear mixed-effects models were used to assess changes in physical activity (MET minutes per week) between the groups during the 6-month trial. Secondary outcomes included sedentary time (minutes/week), BMI, and systolic and diastolic blood pressures. Results: An adherence goal of >80% was achieved for both arms. Total mean physical activity increased by 2,197 MET minutes per week more in the intervention group (p

Objective: To examine the effects of a 6-month weight loss intervention on physical function, inflammatory biomarkers, and metabolic biomarkers in both those with and without osteoarthritis (OA). Design: 59 individuals ≥60 years old with obesity and a functional impairment were enrolled into this IRB approved clinical trial and randomized into one of two 6-month weight loss arms: a higher protein hypocaloric diet or a standard protein hypocaloric diet. All participants were prescribed individualized 500-kcal daily-deficit diets, with a goal of 10% weight loss. Additionally, participants participated in three, low-intensity, exercise sessions per week. Physical function, serum biomarkers and body composition data were assessed at the baseline and 6-month timepoints. Statistical analyses assessed the relationships between biomarkers, physical function, body composition, and OA status as a result of the intervention. Results: No group effects of dietary intervention were detected on any outcome measures (multiple p ​> ​0.05). During the 6-month trial, participants lost 6.2 ​± ​4.0% of their bodyweight (p ​

Background/Purpose: The increasing prevalence of overweight and obese children and adolescents has been recognized as a public health threat worldwide. This study aimed to assess the effect of a stepwise lifestyle intervention in children and adolescents. Methods: We developed a multidisciplinary clinic aimed at providing lifestyle interventions for obese children and adolescents. The program comprised three stages with stepwise goals: knowledge building (the first 4 weeks), habit consolidation (5–12 weeks), and self-monitoring (13–20 weeks). Results: Of the 63 participants (age 11.6 ± 3.2 years) who entered the first stage of the program, 48, 22, and 15 completed the first, second and third stages (4, 12, and 20 weeks), respectively. In the first stage, significant improvement was noted in body weight, body mass index (BMI), BMI z-score, and waist circumference. Improvements in physical fitness performance were observed at 4 weeks in 3/5 items and at 12 weeks in 4/5 items. The decreases in body weight, BMI and BMI z-score were most prominent in the first two stages. In the third stage, participants maintained a stable body weight. In the 15 subjects who completed the whole program, BMI decreased from 29.3 ± 6.9 to 27.8 ± 6.1 (P = 0.001), and BMI z-score decreased from 3.06 ± 0.96 to 2.69 ± 0.91(P = 0.001). Conclusion: We developed a feasible multidisciplinary program based on knowledge education and individualized training. BMI and physical fitness scores can be used as early indicators of lifestyle change for obese children and adolescents.

Objective: To assess the feasibility and acceptability of a culturally-adapted Women's Wellness After Cancer Programme (WWACPHK) for improving health-related quality of life, anxiety and depressive symptoms and enhancing self-efficacy in engaging in healthy lifestyles among Chinese women treated for gynaecological cancer. Methods: This pilot randomised controlled trial was conducted from May to December 2018. Twenty-six women aged 18 or above who had completed treatment for gynaecological cancer were recruited from a gynaecology outpatient clinic of a public hospital in Hong Kong. They were randomised into intervention (n = 15) or control (n = 11) groups. All data collectors were blinded to the group allocation. Intervention participants were given access to the WWACPHK website and an online discussion forum facilitated by a trained research nurse for 12 weeks, while control participants received standard care. Trial feasibility was assessed by recruitment, consent, and retention rates and website use. Acceptability was explored through semi-structured interviews. Additionally, we trialed the data collection procedure and collected preliminary data on health-related quality of life, anxiety and depressive symptoms, dietary and exercise self-efficacy. Results: Of the 26 participants (Median age = 53.5 years) randomised, three participants dropped out of the study. Recruitment, consent and retention of participants and website use were satisfactory. No posting was made on the discussion forum. The intervention participants (n = 13) exhibited significantly greater improvement than the controls (n = 10) in perceived self-efficacy in adhering to an exercise routine at post-intervention (Cohen's d effect size(d) = 1.06, 95% confidence interval (CI): 0.18, 1.92) and 12-weeks after completion (d = 1.24, 95% CI: 0.32, 2.13). All participants were satisfied with the intervention. Conclusions: The WWACPHK is feasible and acceptable to Chinese women treated for gynaecological cancer and may improve their exercise self-efficacy. A larger-scale study is required to confirm its effects. Trial registration https://www.isrctn.com identifier: ISRCTN12149499.

Alcohol use is a major risk factor for noncommunicable diseases in Thailand, and one of its pathways is high blood pressure. Given that brief intervention can effectively reduce hazardous alcohol consumption, this study aimed to investigate how hypertensive patients with concomitant alcohol use are identified and treated in Thai primary care settings and what this may mean for screening and lifestyle intervention strategies. In a cross-sectional, mixed-method design, we surveyed 91 participants from three different groups of Thai stakeholders: policy- and decisionmakers; healthcare practitioners; and patients diagnosed with hypertension. Data was collected between December 2020 and May 2021. Responses were analyzed descriptively and using open coding tools to identify current practices, barriers, facilitators, and implications for interventions. All stakeholder groups regarded alcohol use as an important driver of hypertension. While lifestyle interventions among hypertensive patients were perceived as beneficial, current lifestyle support was limited. Barriers included limited resources in primary healthcare facilities, lack of continuous monitoring or follow-up, missing tools or procedures for risk assessment and lifestyle intervention, and stigmatization of alcohol use. Our results suggest that although screening for lifestyle risk factors (including alcohol use) and lifestyle interventions are not yet sufficiently established, a wide range of stakeholders still recognize the potential of interventions targeted at hazardous alcohol use among hypertensive patients. Future interventions may establish standardized assessment tools, be tailored to high-risk groups, and include electronic or remote elements.

Background: Current recommendations for weight loss in individuals with prediabetes come from individual trials and are derived from older data., Objective: To elucidate the dose-dependent impacts of weight loss on participants with prediabetes to determine the optimal magnitude of weight loss required for the implementation of the most effective diabetes prevention program., Methods: We searched PubMed, Scopus, CENTRAL, CINAHL, and grey literature sources to September 2023 for randomized trials ≥6 months that evaluated the efficacy of a lifestyle weight loss intervention on participants with prediabetes. We conducted random-effects pairwise meta-analyses to calculate relative and absolute effects. We performed one-stage weighted mixed-effects meta-analysis to elucidate the dose-response curves., Results: 44 randomized trials with 14,742 participants with prediabetes (intervention duration range: 6 to 72 months [median=24 months], average weight loss range: 1% to 9%) were included. Lifestyle weight loss interventions increased regression to normoglycemia by 11 per 100 participants (95%CI: 8 more, 17 more; risk ratio: 1.51, 95%CI: 1.27, 1.80; n=20 trials, GRADE=moderate), and reduced progression to type 2 diabetes by 8 per 100 participants (95%CI: 11 fewer, 6 fewer; risk ratio: 0.59, 95%CI: 0.51, 0.67; n=37, GRADE=moderate). There were no significant or credible differences among subgroups categorized by the type and duration of intervention. Dose-response meta-analyses indicated that the risk of regression to normoglycemia increased and the risk of progression to type 2 diabetes declined in a linear pattern within the range of weight loss from 1% to 9%., Conclusions: Over a median duration of 24 months, with weight loss ranging from 1% to 9%, the relationship between weight loss and the progression to type 2 diabetes, as well as the regression to normoglycemia, follows a linear pattern. Any form of lifestyle weight loss interventions including diet, exercise, or a combination of both, can have beneficial impacts on participants with prediabetes., Protocol Registration: PROSPERO (CRD42023465322)., (Copyright © 2024 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Background: Breast cancer poses a significant threat to women's health worldwide. This study aimed to evaluate the association between various levels of physical activity and the incidence of breast cancer., Methods: The data for this study were obtained from the National Health and Nutrition Examination Survey (NHANES), spanning 2011 to 2020. The study included female participants aged 20 years or older, who provided detailed data on breast cancer incidence, physical activity levels, and other pertinent variables. Adjusted odds ratios (ORs) and 95 % confidence intervals (CIs) were calculated using multivariate logistic regression analyses, alongside subgroup and sensitivity analyses., Results: After adjusting for potential confounders, multivariate logistic regression analyses indicated that compared to individuals with low physical activity (<600 METs min/week), light physical activity (600 to < 1800 METs min/week), moderate physical activity (1800 to < 3000 METs min/week) and high physical activity (≥3000 METs min/week) were associated with breast cancer with adjusted ORs of 0.95 (95 % CI 0.68-1.34, P = 0.787), 0.92 (95 % CI 0.57-1.49, P = 0.747), and 0.56 (95 % CI 0.37-0.86, P = 0.009) respectively. These results were consistent across sensitivity and subgroup analyses., Conclusion: High-intensity physical activity may decrease the risk of breast cancer, highlighting the importance of proactively implementing healthy lifestyle interventions to protect the health of adult women., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Personalized nutrition (PN) has been proposed as a strategy to increase the effectiveness of dietary recommendations and ultimately improve health status., Objectives: We aimed to assess whether including omics-based PN in an e-commerce tool improves dietary behavior and metabolic profile in general population., Methods: A 21-wk parallel, single-blinded, randomized intervention involved 193 adults assigned to a control group following Mediterranean diet recommendations (n = 57, completers = 36), PN (n = 70, completers = 45), or personalized plan (PP, n = 68, completers = 53) integrating a behavioral change program with PN recommendations. The intervention used metabolomics, proteomics, and genetic data to assist participants in creating personalized shopping lists in a simulated e-commerce retailer portal. The primary outcome was the Mediterranean diet adherence screener (MEDAS) score; secondary outcomes included biometric and metabolic markers and dietary habits., Results: Volunteers were categorized with a scoring system based on biomarkers of lipid, carbohydrate metabolism, inflammation, oxidative stress, and microbiota, and dietary recommendations delivered accordingly in the PN and PP groups. The intervention significantly increased MEDAS scores in all volunteers (control-3 points; 95% confidence interval [CI]: 2.2, 3.8; PN-2.7 points; 95% CI: 2.0, 3.3; and PP-2.8 points; 95% CI: 2.1, 3.4; q < 0.001). No significant differences were observed in dietary habits or health parameters between PN and control groups after adjustment for multiple comparisons. Nevertheless, personalized recommendations significantly (false discovery rate < 0.05) and selectively enhanced the scores calculated with biomarkers of carbohydrate metabolism (β: -0.37; 95% CI: -0.56, -0.18), oxidative stress (β: -0.37; 95% CI: -0.60, -0.15), microbiota (β: -0.38; 95% CI: -0.63, -0.15), and inflammation (β: -0.78; 95% CI: -1.24, -0.31) compared with control diet., Conclusions: Integration of personalized strategies within an e-commerce-like tool did not enhance adherence to Mediterranean diet or improved health markers compared with general recommendations. The metabotyping approach showed promising results and more research is guaranteed to further promote its application in PN. This trial was registered at clinicaltrials.gov as NCT04641559 (https://clinicaltrials.gov/study/NCT04641559?cond=NCT04641559&rank=1)., (Copyright © 2024. Published by Elsevier Inc.)

Summary: Background: Exercise is advised for young adults with elevated blood pressure, but no trials have investigated efficacy at this age. We aimed to determine whether aerobic exercise, self-monitoring and motivational coaching lowers blood pressure in this group. Methods: The study was a single-centre, open, two-arm, parallel superiority randomized clinical trial with open community-based recruitment of physically-inactive 18–35 year old adults with awake 24 h blood pressure 115/75mmHg-159/99 mmHg and BMI37 weeks) to the intervention group, who received 16-weeks aerobic exercise training (three aerobic training sessions per week of 60 min per session at 60–80% peak heart rate, physical activity self-monitoring with encouragement to do 10,000 steps per day and motivational coaching to maintain physical activity upon completion of the intervention. The control group were sign-posted to educational materials on hypertension and recommended lifestyle behaviours. Investigators performing statistical analyses were blinded to group allocation. The primary outcome was 24 h awake ambulatory blood pressure (systolic and diastolic) change from baseline to 16-weeks on an intention-to-treat basis. Clinicaltrials.gov registered on March 30, 2016 (NCT02723552). Findings: Enrolment occurred between 30/06/2016-26/10/2018. Amongst the 203 randomized young adults (n = 102 in the intervention group; n = 101 in the control group), 178 (88%; n = 76 intervention group, n = 84 control group) completed 16-week follow-up and 160 (79%; n = 68 intervention group, n = 69 control group) completed 52-weeks follow-up. There were no group differences in awake systolic (0·0 mmHg [95%CI, -2·9 to 2·8]; P = 0·98) or awake diastolic ambulatory blood pressure (0·6 mmHg [95%CI, -1·4. to 2·6]; P = 0·58). Aerobic training increased peak oxygen uptake (2·8 ml/kg/min [95%CI, 1·6 to 4·0]) and peak wattage (14·2watts [95%CI, 7·6 to 20·9]) at 16-weeks. There were no intervention effects at 52-weeks follow-up. Intepretation: These results do not support the exclusive use of moderate to high intensity aerobic exercise training for blood pressure control in young adults. Funding: Wellcome Trust, British Heart Foundation, National Institute for Health Research, Oxford Biomedical Research Centre.

Pre-eclampsia (PE) is a multisystem progressive disorder affecting 3–5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term. The effectiveness of a family-centered lifestyle intervention to lower CVD risk in PE families has not previously been evaluated. In the current FINNCARE study, we prospectively compare CVD risk and CVD progression in PE families (mother, father and child) in a cross-sectional study setting 8–12 years from delivery with non-PE control families of comparable age. Furthermore, we evaluate the effectiveness and feasibility of an interactive web-based behavioral 12-month lifestyle intervention to reduce blood pressure and the CVD risk profile overall in a randomized controlled trial. In total, 300 PE families will be randomized 1:1 to a PE-intervention or a PE-control group, and the 100 non-PE control families similarly followed-up at 12 months. Primary outcome is 24-hour mean systolic BP change from baseline in mother and child. Study aims to provide information on CVD progression and CVD risk management in the family following PE.

Endometrial cancer is the most common gynaecological malignancy in Australia. Epidemiological studies have widely documented the association of endometrial cancer with modifiable lifestyle risk factors, most notably obesity. However, preventative strategies for endometrial cancer have not been well reported. The objective of this systematic review was to identify interventions targeted towards modifiable lifestyle risk factors that may reduce the risk of endometrial cancer. Literature published in the past ten years (January 2010 – January 2021) was retrieved from PubMed, Embase and Web of Science literature databases. Of 593 studies potentially eligible, 41 were assessed in full-text, and nine studies were included in the systematic review and synthesis without meta-analysis following the SWiM guidelines. The included studies were highly heterogenous with respect to the type of interventions implemented and the outcomes measured. We identified that diet and physical activity interventions, surgical weight loss interventions, and hormonal interventions were associated with changes in endometrial cancer biomarkers including circulating hormones and tissue markers. We identified a reduction in endometrial proliferation following lifestyle intervention as measured by the ki-67 proliferation index. Furthermore we identified an increase in adiponectin (a circulating biomarker of adiposity) following lifestyle intervention and a reduction in circulating insulin levels following lifestyle intervention. This review highlighted that the area of endometrial cancer prevention research is in its infancy and that further investigation of diet and physical activity interventions, surgical weight loss interventions, and hormonal interventions should be undertaken due to promising preliminary evidence.

Background: Midlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults., Methods and Study Design: The Food Resources and Kitchen Skills plus Aerobic Training (FoRKS+) study is a 2-arm, single-blinded trial that compares those receiving the FoRKS+ program (target N = 64) versus those receiving enhanced usual care (target N = 64) in local federally-qualified health centers. Key eligibility criteria include self-identified NHB adults between ages 35-75 with a mean systolic blood pressure ≥ 130 mm/Hg obtained from 24-h ambulatory blood pressure monitoring. The FoRKS+ program includes 5 weeks of hypertension self-management courses, 11 weeks of nutrition courses, and 12 weeks of aerobic training in dietitian and health coach-led virtual groups. We will collect data on primary cognitive outcomes, feasibility, hypothesized intervention mediators and moderators, and demographic and health covariates at baseline, near intervention weeks 16-, and 28 (primary outcome assessment), and week 52 follow-up. We will use mixed-effects modeling to examine intervention effects on cognition., Discussion: This pilot RCT will examine the feasibility and preliminary effects of a multicomponent lifestyle intervention on cognitive function in NHB adults, which may have implications for reducing health disparities in ADRD., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Eating-related problems (e.g., binge eating (BE)) and impaired quality of life (QoL) is more prevalent in children with overweight and obesity. This study aimed to investigate changes in self-reported overeating (OE), BE, and QoL in children with overweight or obesity attending multicomponent 10-week lifestyle camps with a 52-weeks follow-up. Additionally, the study sought to investigate whether self-reported OE/BE before camp was associated with changes in QoL., Methods: Children aged 7 to 14-years could attend camp if they had overweight/obesity, were lonely, unhappy, or had social or family-related problems. In this study only children with overweight and obesity were included (n:185). OE, BE, and QoL were measured using self-reported questionnaires., Results: In total, 38 % of the children reported regular BE at baseline. Regular OE, occasional BE, and occasional OE was reported by 14 %, 13 %, and 11 %, respectively, while 24 % reported no eating-related problems. The relative risk of experiencing eating-related problems decreased at 10-weeks compared to baseline. Additionally, the probability of regular OE (RR 0.12 (95 % CI 0.04;0.38) (X 2 = 8.44, p = 0.004)) and regular BE (RR 0.01 (95 % CI 0.00;0.11) (X 2 = 9.91, p = 0.002)) remained lower at 52-weeks relative to baseline. All QoL dimensions improved after camp, and the presence of self-reported OE and regular BE at baseline was significantly associated with lower QoL at baseline, 10 and 52-weeks., Conclusion: Children self-reporting OE and BE may be a particular vulnerable group that needs more support from camp staff and healthcare professionals to improve QoL., Clinical Trial Registration: clinicaltrials.gov with ID: NCT04522921., Competing Interests: Declaration of Competing Interest The authors declare no competing interest related to the present study., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The health benefits of the Mediterranean diet (MedDiet) have been linked to the presence of beneficial gut microbes and related metabolites. However, its impact on the fecal metabolome remains poorly understood., Objectives: Our goal was to investigate the weight-loss effects of a 1-y lifestyle intervention based on an energy-reduced MedDiet coupled with physical activity (intervention group), compared with an ad libitum MedDiet (control group), on fecal metabolites, fecal microbiota, and their potential association with cardiovascular disease risk factors., Methods: A total of 400 participants (200 from each study group), aged 55-75 y, and at high cardiovascular disease risk, were included. Dietary and lifestyle information, anthropometric measurements, blood biochemical parameters, and stool samples were collected at baseline and after 1 y of follow-up. Liquid chromatography-tandem mass spectrometry was used to profile endogenous fecal metabolites, and 16S amplicon sequencing was employed to profile the fecal microbiota., Results: Compared with the control group, the intervention group exhibited greater weight loss and improvement in various cardiovascular disease risk factors. We identified intervention effects on 4 stool metabolites and subnetworks primarily composed of bile acids, ceramides, and sphingosines, fatty acids, carnitines, nucleotides, and metabolites of purine and the Krebs cycle. Some of these were associated with changes in several cardiovascular disease risk factors. In addition, we observed a reduction in the abundance of the genera Eubacterium hallii group and Dorea, and an increase in alpha diversity in the intervention group after 1 y of follow-up. Changes in the intervention-related microbiota profiles were also associated with alterations in different fecal metabolite subnetworks and some cardiovascular disease risk factors., Conclusions: An intervention based on an energy-reduced MedDiet and physical activity promotion, compared with an ad libitum MedDiet, was associated with improvements in cardiometabolic risk factors, potentially through modulation of the fecal microbiota and metabolome. This trial was registered at https://www.isrctn.com/ as ISRCTN89898870 (https://doi.org/10.1186/ISRCTN89898870)., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.

Whānau Pakari is a family-centred healthy lifestyle programme for children/adolescents with overweight/obesity in New Zealand. This secondary analysis from our randomised trial within the clinical service assessed 5-year BMI changes in accompanying caregivers (n = 23), mostly mothers. Overall, baseline and 5-year caregivers' BMI were similar (32.50 vs 31.42 kg/m 2 , respectively; p = 0.31) but two-thirds (65%) experienced BMI reductions. Five-year BMI change was similar in High-intensity and Low-intensity randomisation groups [-1.37 kg/m 2 (-4.95, 2.21); p = 0.44]. Caregiver's BMI change was not associated with child's BMI change. Despite no overall BMI reduction, our findings contrast with upward BMI trajectories predicted for NZ adults with overweight/obesity., Competing Interests: Declaration of Competing Interest None., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Postnatal depression (PND) is a leading cause of illness and death among women following childbirth. Physical inactivity, sedentary behaviour, poor sleep, and sub-optimal diet quality are behavioural risk factors for PND. A feasible, sustainable, and scalable intervention to improve healthy behaviours and reduce PND symptoms among women at postpartum is needed. This study aims to examine the effectiveness of a multi-behavioural home-based program Food, Move, Sleep (FOMOS) for Postnatal Mental Health designed to improve PND symptoms in women at postpartum., Methods: This randomised clinical trial will recruit 220 Australian women (2-12 months postpartum) experiencing heightened PND symptoms (Edinburgh Postnatal Depression Scale score ≥ 10). Participants will be randomised to FOMOS or wait-list control receiving standard clinical care. FOMOS is a 6-month mobile health (mHealth) intervention targeting diet quality, physical activity, sedentary behaviour, sleep, and mental health. The intervention, informed by the Social Cognitive Theory and incorporating behaviour change techniques defined in the CALO-RE taxonomy and Cognitive Behavioural Treatment of Insomnia, provides exercise equipment, and educational/motivational material and social support via mHealth and social media. Data collection pre-intervention and at 3, 6 and 12 months will assess the primary outcome of PND symptoms and secondary outcomes (diet quality, physical activity, sitting time, sleep quality) using self-report and device measures. Process evaluation will explore acceptability, appropriateness, cost-effectiveness, feasibility, and sustainability via analytic tools, record keeping, interviews, and surveys., Discussion: If effective, FOMOS could be a feasible and potentially scalable management strategy to support improvement of health behaviours and mental health for women with PND symptoms., Trial Registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622001079730p., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Inc.)

The prevalence of obesity in India is increasing and ranges from 8% to 38% in rural and 13% to 50% in urban areas. Obesity is a risk factor for development of type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, coronary heart disease and many cancers. In Asian Indians excess abdominal and hepatic fat is associated with increased risk for T2DM and cardiovascular disease. There is higher risk for development of obesity related non-communicable diseases at lower body mass index levels, compared to white Caucasians. Despite being a commonly encountered medical problem, obesity poses challenges in treatment. Many Indian physicians find themselves to be lacking time and expertise to prepare an appropriate obesity management plan and patients experience continuous weight gain over time despite being under regular medical supervision. In this article, we outline approaches to obesity management in ‘real life mode’ and in context to Asian Indian patients.

Background: Obesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA., Methods: POWER randomizes 696 patients with obesity (BMI 30-45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation., Conclusions: The results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost., Competing Interests: Declaration of Competing Interest Dr. Au reports personal fees from Boehringer Ingelheim for service on an advisory board and personal fees from Annals of the American Thoracic Society for service as a deputy editor. Dr. Donovan reports honorarium from the American Academy of Sleep Medicine for teaching at a post-graduate course., (Copyright © 2023. Published by Elsevier Inc.)

Background: Low-income Hispanic families face marked disparities in obesity, but interventions for obesity prevention and treatment have rarely been designed with this population as a focus. Hispanic culture is characterized by Familism, a value that prioritizes familial respect, cooperation, and togetherness. We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment intervention designed around the value Familism and addressing food insecurity., Methods/design: This two-group randomized comparative effectiveness trial will compare the effects of HeLP versus a primary care counseling intervention (Recommended Treatment of Obesity in Primary Care, or RTOP) on decreasing body mass index (BMI; kg/m 2 ) in Hispanic children 2-16 years of age with obesity and preventing BMI increase among siblings without obesity. 164 families per arm will be recruited from primary care practices. Families randomized to HeLP will participate in 12 two-hour sessions, followed by booster sessions. HeLP sessions include family meals and instruction in parenting skills, nutrition, culinary skills, fitness, and mindfulness delivered at community recreation centers by bilingual health educators and athletic trainers. Families randomized to RTOP will be offered individual visits in primary care every 3 months throughout the 18-month follow-up period. Secondary outcomes include changes to objectively measured child fitness, the home environment related to nutrition, physical activity, and media usage, food insecurity, child eating behaviors, quality of life, parent BMI and waist circumference, and implementation outcomes., Discussion: This protocol paper describes the rationale and planned methods for the comparative effectiveness trial., Trial Registration: Clinicaltrials.gov Identifier NCT05041855 (6/13/2023)., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study., Methods: REAL-T is a two-arm randomized controlled trial that recruited 18-30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures., Results: The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations., Conclusion: The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Inc.)

Background: Intrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring., Methods: This two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28-32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies., Conclusion: This clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To describe the development, implementation and lessons learned of lifestyle intervention to promote appropriate gestational weight gain among Hispanic pregnant women. Design: The intervention was informed by an empowerment oriented theoretical framework, and targeted women in the Pregnancy and Early Life Improvement Study. Methods: The nutrition component consisted of recommendations for total calories, food quantity and improving carbohydrate and fat quality. We provided brown rice, omega-3 rich vegetable oil and spread, and water monthly. The physical activity focused on limiting sedentary behavior and promoting regular movement. The intervention was delivered through individual and group sessions and phone calls. Participants set their own goals, which were closely monitored. The intervention was evaluated extracting data from participant's record (attendance, goals, and challenges) and using a questionnaire. Results: Participants were from underserved communities with economic, time, cultural and social barriers for engaging in lifestyle interventions. Modifications were done to facilitate participation, such as coordinating sessions with prenatal appointments and reducing group size and duration of sessions. Weekly text messages were added to reinforce the intervention. The main goal chosen by participants was reduction of sweetened beverages. The greatest challenges were replacing white rice with brown rice and improving physical activity. Participants suggested conducting sessions near their community and using social media as a motivation tool. Main outcomes results will be published elsewhere. Conclusion: We identified barriers to delivering the lifestyle intervention, mainly related to group session's participation. Sessions should be conducted in the community, using text messages and social media as reinforcement. ClinicalTrials.gov: NCT01771133.

Background: Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking., Objective: This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus., Study Design: A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods., Results: In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns=38/102 [37%] intervention vs 25/91 [28.0%] control; P=.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 [3.4-6.0] vs 0.7 [-0.9 to 2.3] kg; P=.001) and a greater proportion lost ≥5% of body weight (50.0% [17/34] vs 13.6% [3/22]; P=.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% [ns=23/38]) and the control group (44.0% [ns=11/25]; odds ratio, 1.8 [0.59-5.8]). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 [0.66-0.94]; P=.008). A ≥5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 [0.04-0.88]; P=.03)., Conclusion: Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Treatments that delay progression of cognitive impairment in older adults are of great public health significance. This manuscript outlines the protocol, recruitment, baseline characteristics, and retention for a randomized controlled trial of cognitive and aerobic physical training to improve cognition in individuals with subjective cognitive dysfunction, the "Cognitive and Aerobic Resilience for the Brain" (CARB) study., Methods: Community-dwelling, older adults with self-reported memory loss were randomly assigned to receive either computer-based cognitive training, aerobic physical training, combined cognitive and physical training, or education control. Treatment was delivered 2- to 3-times per week in 45- to 90-min sessions for 12 weeks by trained facilitators videoconferencing into subject's home. Outcome assessments of were taken at the baseline, immediately following training, and 3-months after training., Results: 191 subjects were randomized into the trial (mean age, 75.5 years; 68% female; 20% non-white; mean education, 15.1 years; 30% with 1+ APOE e4 allele). The sample was generally obese, hypertensive, and many were diabetic, while cognition, self-reported mood, and activities of daily living were in the normal range. There was excellent retention throughout the trial. Interventions were completed at high rates, participants found the treatments acceptable and enjoyable, and outcome assessments were completed at high rates., Conclusions: This study was designed to determine the feasibility of recruiting, intervening, and documenting response to treatment in a population at risk for progressive cognitive decline. Older adults with self-reported memory loss were enrolled in high numbers and were well engaged with the intervention and outcome assessments., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Understanding the effect lifestyle intervention (LI) has on important psychological and behavioral variables that are associated with weight loss can help inform LI design, content, and delivery., Objective: The aim was to determine the modifiable psychological and behavioral factors that are associated with percent weight loss (%WL) and their relative importance in predicting %WL at 12, 24, and 36 months in the REAL HEALTH-Diabetes randomized controlled trial LI., Design: This is a secondary analysis of LI arms of the REAL HEALTH-Diabetes randomized controlled trial LI cohort over a 24-month intervention period and 12-month follow-up period. Patient-reported outcomes were measured using validated questionnaires that were either self-administered or administered by a research coordinator., Participants/setting: Adults with type 2 diabetes and overweight/obesity (N = 142) from community health centers, primary care, and local endocrinology practices affiliated with Massachusetts General Hospital in Boston, MA, between 2015 and 2020, were randomized to LI and were included in the analysis., Intervention: The LI was a lower intensity adaptation of Look Action for Health in Diabetes's (HEALTH) evidence-based LI delivered either in-person or via telephone. Registered dietitians delivered 19 group sessions during the first 6 months followed by 18 monthly sessions., Main Outcome Measures: The association of psychological (diabetes-related distress, depression, autonomous motivation, diet and exercise self-efficacy, and social support for healthy behaviors) and behavioral (fat-related diet and dietary self-regulation) variables with %WL., Statistical Analysis: Baseline and 6-month change scores in psychological and behavioral variables were modeled as predictors of %WL at 12, 24, and 36 months using linear regression. Random forests were used to compare the relative importance of changes in the variables in predicting %WL., Results: Six-month improvement in autonomous motivation, exercise self-efficacy, diet self-efficacy, and dietary self-regulation were associated with %WL at 12 and 24 months, but not at 36 months. Improvement in fat-related diet behavior and depressive symptoms were the only variables associated with %WL at all three timepoints. Autonomous motivation, dietary self-regulation, and low-fat diet behaviors were the three most important predictors of %WL during the 2-year LI., Conclusions: The REAL HEALTH-Diabetes randomized controlled trial LI resulted in 6-month improvements in modifiable psychological and behavioral factors that were associated with %WL. LI programs for weight loss should focus on skills and strategies to promote autonomous motivation, flexible dietary self-regulation, and habituation of low-fat eating habits during the intervention period., (Copyright © 2023 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Background: Previous research highlights the need for effective lifestyle interventions for men. Hockey Fans in Training (Hockey FIT) was developed as a pragmatic healthy lifestyle program tailored to men with overweight or obesity. This paper overviews the rationale, program details, and design of a recently completed cluster randomized controlled trial (RCT) of Hockey FIT. Participant engagement and baseline characteristics are also described., Methods: The RCT evaluated the effectiveness, cost-effectiveness, and implementation of Hockey FIT. Forty-two sites in Canada and the United States were randomized to either the Hockey FIT intervention group or wait-list control group. Participants were men, aged 35-65 years, with a body mass index (BMI) ≥27 kg/m 2 . Hockey FIT is a group-based, off-ice, in-person healthy lifestyle program, including both a 3-month active phase and a 9-month minimally-supported phase. Outcomes were assessed at baseline, 3, and 12 months. The primary outcome was weight loss at 12 months., Results: The design of the cluster RCT incorporates evaluations of participant health outcomes, program implementation, and broader healthcare system impact. In the RCT, 1397 participants were assessed for eligibility and 997 were enrolled. Most participants heard about the program through social media or hockey team emails. Participants averaged 49 years of age, had BMI values of 35.3 kg/m 2 , were predominately white, and had varying levels of education., Conclusion: The intended audience for Hockey FIT was recruited successfully, however, targeted recruitment to better engage diverse populations is warranted. This paper affords a useful outline for evaluating future lifestyle interventions tailored to men. This trial was registered on August 17, 2018 with ClinicalTrials.gov (identifier: NCT03636282)., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background and Aims: Obstructive sleep apnea (OSA) and the metabolic syndrome (MS) frequently coexist and lead to increased cardiometabolic morbidity. We aimed to explore the long-term cardiometabolic benefits of a weight-loss Mediterranean diet/lifestyle intervention in OSA., Methods and Results: As many as 180 adults with overweight/obesity and polysomnography-diagnosed moderate-to-severe OSA were randomized to a standard care (SCG, n = 62), a Mediterranean diet (MDG, n = 59) or a Mediterranean lifestyle group (MLG, n = 59). All groups were prescribed with continuous positive airway pressure (CPAP), while intervention arms (MDG/MLG) additionally participated in a 6-month weight-loss intervention based on the Mediterranean diet/lifestyle. Cardiometabolic parameters were evaluated at baseline and 12 months (6 months post-intervention). Data were analyzed using the intention-to-treat method, and 12-month between-group differences were explored while adjusting for age, sex, baseline status and CPAP use. Compared to the SCG, intervention arms exhibited lower insulin, triglycerides and high-sensitivity C-reactive protein, and higher high-density lipoprotein cholesterol; the MDG also exhibited lower diastolic blood pressure, while the MLG exhibited lower glucose and systolic blood pressure (all P < 0.050). The relative risk (95% confidence interval) of MS was 0.60 (0.36, 0.99) in the MDG versus the SCG, 0.33 (0.20, 0.55) in the MLG versus the SCG and 0.55 (0.32, 0.93) in the MLG versus the MDG. The risk of MS remained lower in the MLG versus the other study groups (both P < 0.050) after additional adjustment for body weight change., Conclusion: Cardiometabolic benefits of a 6-month healthy dietary/lifestyle intervention are sustainable 6 months post-intervention in OSA., Trial Registration: ClinicalTrials.gov, NCT02515357, August 4, 2015., Competing Interests: Declaration of competing interest The authors report no conflict of interest., (Copyright © 2023 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Objective: To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes., Methods: Using data from a randomized control trial of digital diabetes prevention program (d-DPP) with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d-DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of participants over time for specific CVD risk factors using generalized estimating equations., Results: We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d-DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a significant group difference at 4 months (-0.96%; 95% confidence interval: -1.58%, -0.34%) (but not at 12 months). Additionally, we observed that the d-DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points., Conclusions: Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

Background & objectives: There is poor knowledge and behaviors regarding chronic diseases related nutritional and lifestyle factors among women in low income countries. To evaluate efficacy of a multilevel population-based intervention in improving knowledge and practices for related factors we performed a study in India. Methods: Population based study among women 35–70 years was performed in four urban and five rural locations. Stratified sampling was performed and we enrolled 4624 (rural 2616, urban 2008) of eligible 8000 women (58%). Demographic details, medical history, diet, physical activity and anthropometry were recorded and blood hemoglobin, glucose and total cholesterol determined. Knowledge and behaviors regarding diet in chronic diseases were inquired in a randomly selected 100 women at each site (n = 900). A systematic multilevel population based intervention (using posters, handouts, street plays, public lectures, group lectures and focused group discussions) was administered over 6 months at each site. The questionnaire was re-administered at the end in random 100 women (n = 900) and differences determined. Descriptive statistics are reported. Comparison of parameters before and after intervention was assessed using Mann Whitney test. Results: Prevalence (%) of chronic disease related lifestyles and risk factors in rural/urban women, respectively, was illiteracy in 63.6/29.4, smoking/tobacco use 39.3/18.9, high fat intake 93.6/93.4, high salt intake 18.2/12.6, low physical activity 59.5/70.2, overweight/obesity 22.5/45.6, truncal obesity 13.0/44.3, hypertension 31.6/48.2, hypercholesterolemia 13.5/27.7, and diabetes in 4.3/15.1 percent. Composite chronic diseases knowledge at baseline vs after intervention increased significantly in overall (32.0 vs 62.0), rural (29.0 vs 63.5) and urban (39.5 vs 60.5) groups (p

Adipose tissue dysfunction plays a key role in the development of the metabolic abnormalities characteristic of type 2 diabetes (T2DM) and participates actively in lipid metabolism. Adiponectin, found abundantly in circulation and a marker of adipose health, is decreased in obese persons with T2DM. We investigated whether the changes in adiponectin with an intensive lifestyle intervention (ILI) for weight loss could potentially mediate the increase in low HDL-cholesterol (HDL-C) with ILI. Adiponectin and its fractions were determined using an ELISA with selective protease treatment in 1,397 participants from Look AHEAD, a trial examining whether ILI will reduce cardiovascular events in overweight/obese subjects with T2DM when compared with a control arm, diabetes support and education (DSE). Multivariable regression and mediational analyses were performed for adiponectin and its high-molecular-weight (HMW) and non-HMW fractions. ILI increased baseline HDL-C by 9.7% and adiponectin by 11.9%; changes with DSE were 1.3% and 0.2%, respectively (P < 0.0001). In a model including changes in weight, fitness, triglycerides, and glucose control and that adjusted for demographics and medical history, adiponectin changes remained significantly associated with HDL-C change. Data supported the contribution of changes in both HMW- and non-HMW-adiponectin to the improvement in HDL-C with ILI

Background: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear., Objective: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity., Methods: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results., Conclusion: Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions., Clinicaltrials: gov: NCT04828785., Competing Interests: Declaration of Competing Interest SAB reports research grants from NIH, North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and Feeding America, and personal fees from the Aspen Institute, Rockefeller Foundation, Gretchen Swanson Center for Nutrition, and Kaiser Permanente, outside of the submitted work. DJW reports serving on data monitoring committees for Novo Nordisk. JBB's contracted consulting fees and travel support for contracted activities are paid to the University of North Carolina by Novo Nordisk; clinical trial contracts are paid to the University of North Carolina by Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion and vTv Therapeutics; personal compensation for consulting services are received from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion Inc., Boehringer-Ingelheim, CeQur, Cirius Therapeutics Inc., Dasman Diabetes Center (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mediflix, Medscape, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, ReachMD, Stability Health, Valo, and Zealand Pharma; stock/options are provided by Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health. GK has a family financial interest in a digital health company, Dimagi. Inc. and receives grant funding from NIH and Astra-Zeneca administered by the National Comprehensive Cancer Network. TCK has a family financial interest in a company that is a purveyor of healthy frozen meals, Equiti Foods, and receives grant funding from NIH, CDC, and the Duke Endowment. LMD reports consulting fees for WW International, Inc., and Omada Health, Inc. and stock options for JanaCare, Inc. and Omada Health, Inc. PWS reports funding from NIH research grants. JB, EO, BK, CF, and JT report employment by Community Servings but no conflicts., (Copyright © 2022 Elsevier Inc. All rights reserved.)

The effects of exercise training (Ex), dietary interventions (DIs), and a combination of Ex and DI (Ex + DI) on leptin and adiponectin have been established. However, less is known regarding the comparisons of Ex with DI and of Ex + DI with either Ex or DI alone. The aim of the present meta-analysis is to compare the effects of Ex with those of DI and those of Ex + DI with those of either Ex or DI alone on circulating leptin and adiponectin in individuals who are overweight and those with obesity. PubMed, Web of Science, and MEDLINE were searched to identify original articles, published through June 2022, that compared the effects of Ex with those of DI and/or the effects of Ex + DI with those of Ex and/or DI on leptin and adiponectin in individuals with BMIs (in kg/m 2 ) of ≥25 and aged 7-70 y. Standardized mean differences (SMDs), weighted mean differences, and 95% CIs were calculated using random-effect models for outcomes. Forty-seven studies, comprising 3872 participants who were overweight and those with obesity, were included in the current meta-analysis. DI reduced the concentration of leptin (SMD: -0.30; P = 0.001) and increased the concentration of adiponectin (SMD: 0.23; P = 0.001) compared with Ex, as did Ex + DI (leptin: SMD: -0.34; P = 0.001; adiponectin: SMD: 0.37; P = 0.004) compared with Ex alone. However, Ex + DI did not affect the concentration of adiponectin (SMD: 0.10; P = 0.11) and led to inconsistent and nonsignificant changes in the concentration of leptin (SMD: -0.13; P = 0.06) compared with DI alone. Subgroup analyses showed that age, BMI, duration of intervention, type of supervision, quality of the study, and magnitude of energy restriction are sources of heterogeneity. Our results suggest that Ex alone was not as effective as DI or Ex + DI for decreasing leptin and increasing adiponectin in individuals with overweight and obesity. However, Ex + DI was not more effective than DI alone, suggesting that diet plays a critical role in beneficially altering the concentrations of leptin and adiponectin. This review was registered at PROSPERO as CRD42021283532., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)