Clinical Research Directory

Community-Based Time-Restricted Eating and Health Education for Adults With Stage 1-2 Cardiovascular-Kidney-Metabolic Syndrome in Can Tho City

This study evaluates the effectiveness of a community-based intervention for adults aged 30 years and older with stage 1-2 cardiovascular-kidney-metabolic syndrome who do not currently have an indication for pharmacotherapy in Can Tho City, Vietnam. The study uses a cluster-controlled community intervention design. Participants are assigned to either an intervention group or a control group and are assessed at baseline, 3 months, and 6 months. During the 6-month intervention, participants in the intervention group follow a time-restricted eating regimen with a fixed 10-hour daily eating window. All energy-containing foods and beverages are consumed within the selected eating window; outside this period, participants may consume only water or noncaloric beverages as instructed by the study team. Time-restricted eating is combined with health education on cardiovascular-kidney-metabolic syndrome, healthy nutrition, physical activity, weight management, and self-management of health risks. Participants receive regular monitoring, counseling, and reminders through in-person assessments, telephone contact. Participants in the control group continue their usual eating patterns, daily activities, and routine community-based healthcare and do not receive the structured time-restricted eating program. The primary outcome is the proportion of participants whose cardiovascular-kidney-metabolic syndrome stage improves by at least one stage after 6 months. Secondary outcomes include adherence to time-restricted eating; knowledge and health self-management; dietary behavior; physical activity; smoking and alcohol use; blood pressure; body weight; body mass index; waist circumference; blood glucose; glycated hemoglobin; blood lipids; serum creatinine; estimated glomerular filtration rate; urinary albumin-to-creatinine ratio; and predicted 10-year and 30-year cardiovascular disease risk. Intervention effectiveness will be assessed by comparing changes in these outcomes between the intervention and control groups across the follow-up assessments.