Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07722338 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: CKM
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07722338
Lead Sponsor Can Tho University of Medicine and Pharmacy
Collaborators: National Institute of Hygiene and Epidemiology, Vietnam
Conditions
(from sponsor)
CKM
Related terms Health Education, Intermittent Fasting
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov