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ImportanceSouth Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population.ObjectiveTo evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults.Design, Setting, and ParticipantsThis single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion.InterventionA 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly.Main Outcomes and MeasuresPrimary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models.ResultsAmong 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, −0.07 kg; 95% CI, −0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, −1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, −1.06 to 1.95), cholesterol (mean difference, −2.47 mg/dL; 95% CI, −8.51 to 3.57), and HbA1c (mean difference, −0.07%; 95% CI −0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control.Conclusions and RelevanceIn the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation.Trial RegistrationClinicalTrials.gov Identifier: NCT03336255
ImportanceSouth Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population.ObjectiveTo evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults.Design, Setting, and ParticipantsThis single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion.InterventionA 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly.Main Outcomes and MeasuresPrimary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models.ResultsAmong 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, −0.07 kg; 95% CI, −0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, −1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, −1.06 to 1.95), cholesterol (mean difference, −2.47 mg/dL; 95% CI, −8.51 to 3.57), and HbA1c (mean difference, −0.07%; 95% CI −0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control.Conclusions and RelevanceIn the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation.Trial RegistrationClinicalTrials.gov Identifier: NCT03336255
BACKGROUND The prevalence of weight-related chronic diseases presents a critical challenge to healthcare systems. In Canada, obesity rates are alarmingly high, with significant regional disparities. Obesity is strongly associated with numerous health conditions, including type 2 diabetes, cardiovascular diseases, and hypertension, resulting in considerable societal costs. Effective weight management programs often involve dietary self-monitoring, and mobile health (mHealth) apps. Particularly calorie counting apps, have emerged as promising tools due to widespread smartphone ownership and increased telemedicine utilization. However, the heterogeneity of these apps complicates the assessment of their clinical feasibility and efficacy. OBJECTIVE This study aims to systematically evaluate the structure and content of 46 calorie counting apps, identify predictors of their acceptability and feasibility among adults with obesity or weight-related chronic diseases, and formulate evidence-based recommendations for app developers, clinicians, and researchers. METHODS A comprehensive review and analysis of 46 existing calorie counting apps will be conducted, focusing on their functionalities, features, and user engagement metrics. Additionally, the study will investigate predictors of app acceptability and feasibility through surveys and user feedback from adults with obesity or weight-related chronic conditions. The findings will be synthesized to develop practical recommendations for enhancing the design and clinical implementation of calorie counting apps. RESULTS The review identified significant variety in the functionalities and features of calorie counting apps. Key predictors of acceptability included personalized features, automated functionalities, user-friendly interfaces, and the ability to share data with healthcare professionals. Barriers to acceptability and feasibility were identified as technical issues, limited food databases, and the high effort required for manual entry. The study also highlighted a decline in user adherence over time, emphasizing the need for engaging and simplified calorie tracking methods. CONCLUSIONS Calorie counting apps hold potential as tools for managing obesity and weight-related chronic diseases. To enhance their clinical utility, app developers should focus on improving user engagement through personalized and automated features, ensuring comprehensive food databases, and minimizing the effort required for dietary self-monitoring. Further research is needed to validate these apps' effectiveness and explore strategies to sustain user adherence. The findings provide valuable insights for developing more effective and user-friendly mHealth interventions.
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