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

Summary

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.

Conditions

• CKM

Interventions

BEHAVIORAL

10-Hour Time-Restricted Eating With Health Education and Behavioral Support

Participants receive a 6-month behavioral intervention combining 10-hour time-restricted eating with health education. They select a fixed 10-hour daytime eating window and consume all energy-containing foods and beverages within it; only water or non-caloric beverages are allowed outside the window. Calorie counting is not required. The first 2 weeks serve as an adaptation period. Education covers cardiovascular-kidney-metabolic health, healthy diet, physical activity, weight control, sleep, tobacco and alcohol risk reduction, and warning signs. Support is provided through individual or small-group counseling, printed materials, eating-time diaries, telephone calls, and Zalo messages. Adherence and tolerability are monitored throughout the intervention.

Sponsors & Collaborators

• National Institute of Hygiene and Epidemiology, Vietnam

  collaborator OTHER

• Can Tho University of Medicine and Pharmacy

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2026-11-01

Completion

2026-11-30

Countries

• Vietnam

Study Locations