Active — Not RecruitingNot Applicable

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

Vietnam200 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range

30 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age and residence Aged 30 to 79 years at enrollment. Has resided in the study area for at least 6 months and intends to remain in the area throughout the study period.
. Cardiovascular-kidney-metabolic status Classified as having stage 1 or stage 2 cardiovascular-kidney-metabolic syndrome according to the 2023 American Heart Association staging framework.
. Criteria indicating no current indication for pharmacological treatment. Participants must meet all of the following conditions:
. Ability to participate in the intervention Has access to a smartphone and is able to use Zalo or an eating-time monitoring application.
. Informed consent and study commitment Voluntarily agrees to participate and provides written informed consent after receiving adequate study information.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants With Improvement of at Least One CKM Stage

Timeframe: Baseline and 3 months, 6 months

Adherence to 10-Hour Time-Restricted Eating

Timeframe: From intervention initiation to 3 months and 6 months

Trial details

NCT IDNCT07722338

SponsorCan Tho University of Medicine and Pharmacy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

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