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

NCT07722338 | Active Not Recruiting

• 1 other identifier: NIHE IRB - 36/2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiovascular-Kidney-Metabolic Syndrome; Time-Restricted Feeding; Health Education

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Improvement of at Least One CKM Stage

  A participant is classified as having improved CKM stage when the CKM stage decreases by at least one level from baseline, such as from stage 2 to stage 1 or from stage 1 to stage 0. Participants whose CKM stage remains unchanged, progresses to a higher stage, or who develop an indication for pharmacotherapy during follow-up are classified as not improved. CKM stage improvement is assessed at 3 and 6 months, with the 6-month assessment serving as the primary endpoint.

  Baseline and 3 months, 6 months

• Adherence to 10-Hour Time-Restricted Eating

  Adherence is assessed using daily eating-time records. A day is considered adherent when all energy-containing foods and beverages are consumed within the participant's registered eating window of no more than 10 hours; only water or non-caloric beverages are consumed outside the window. Weekly adherence is recorded as the number of adherent days from 0 to 7. Good weekly adherence is defined as at least 5 adherent days per week. Cumulative adherence is calculated as the number of adherent days divided by the total number of monitored days, multiplied by 100. High cumulative adherence is defined as adherence on at least 80% of monitored days.

  From intervention initiation to 3 months and 6 months

Secondary Outcomes (3)

• Physical activity

  Baseline, 3 months, and 6 months

• Change in Healthy Eating Score Measured by the Rapid Eating Assessment for Participants-Shortened Version, Version 2

  Baseline, 3 months, and 6 months

• Change in Alcohol Use Risk Score Measured by the Alcohol Use Disorders Identification Test

  Baseline, 3 months, and 6 months

Study Arms (2)

10-Hour Time-Restricted Eating and Behavioral Support

EXPERIMENTAL

Participants receive a 6-month multicomponent lifestyle intervention consisting of a self-selected, fixed 10-hour daily eating window, preferably during daytime hours. All energy-containing foods and beverages must be consumed within this window; outside the window, only water or non-caloric beverages are permitted. Formal calorie counting is not required. The program also includes health education on cardiovascular-kidney-metabolic health, healthy eating, physical activity, weight management, sleep, tobacco and alcohol risk reduction, and recognition of warning symptoms. Behavioral support is delivered through individual or small-group counseling, printed materials, eating-time diaries, telephone calls, and Zalo-based communication. Adherence and tolerability are monitored throughout the intervention.

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

Usual Community Healthcare

NO INTERVENTION

Participants continue their usual diet, daily activities, and routine community healthcare for 6 months. They may receive general health advice available through standard local health services but do not receive structured 10-hour time-restricted eating instructions, eating-time diaries, scheduled behavioral counseling, or intervention-specific telephone or Zalo support. They undergo the same study assessments and follow-up schedule as participants in the intervention arm.

Interventions

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

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.

10-Hour Time-Restricted Eating and Behavioral Support

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Assessed by a study physician as not currently having an indication for pharmacological treatment of a cardiovascular, kidney, or metabolic condition.
• Criteria indicating no current indication for pharmacological treatment. Participants must meet all of the following conditions:
• No history or current diagnosis of clinical cardiovascular disease, diabetes mellitus, chronic kidney disease, or glomerular disease.
• Serum albumin concentration of at least 3.5 g/dL, with no clinical or laboratory evidence suggestive of glomerular disease, severe liver disease, malnutrition, or another systemic condition requiring specialist evaluation or treatment.
• No use during the previous 3 months of medications for cardiovascular, kidney, or metabolic conditions, including antihypertensive agents, glucose-lowering medications, lipid-lowering agents, anti-obesity medications, sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, or medications with similar therapeutic purposes. Medication use is assessed through participant interview and review of prescriptions or medical records when available.
• Mean blood pressure below 140/90 mmHg, measured using a standardized study protocol. For participants with a mean systolic blood pressure of 130-139 mmHg or a mean diastolic blood pressure of 80-89 mmHg, the estimated 10-year total cardiovascular disease risk calculated using the PREVENT equation must be below 7.5%.
• Fasting plasma glucose below 126 mg/dL and glycated hemoglobin below 6.5%. Low-density lipoprotein cholesterol below 190 mg/dL. Estimated glomerular filtration rate of at least 60 mL/min/1.73 m² and urinary albumin-to-creatinine ratio below 30 mg/g.
• Body mass index below 30 kg/m². Recruitment will preferentially approach overweight individuals with a body mass index of at least 23 kg/m², but this is not a mandatory eligibility requirement when all other criteria are met.
• Ability to participate in the intervention Has access to a smartphone and is able to use Zalo or an eating-time monitoring application.
• Is able to complete an eating-time diary and attend scheduled health education, counseling, and assessment sessions.
• Informed consent and study commitment Voluntarily agrees to participate and provides written informed consent after receiving adequate study information.
• Agrees to participate in the intervention and follow-up for 6 months, with assessments at baseline, 3 months, and 6 months

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (1)

Can Tho University of Madicine and Pharmacy

Can Tho, Can Tho City, 900000, Vietnam

Location

MeSH Terms

Conditions

Intermittent Fasting; Health Education

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the intervention involves time-restricted eating, health education, and behavioral support delivered directly in community settings, participants and intervention personnel cannot be blinded to group allocation. Data collectors and study investigators are also aware of participants' assigned groups; therefore, the study is conducted as an open-label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel, controlled community-based intervention study with cluster allocation by drawing lots. The allocation unit is the residential-area cluster within four participating wards or communes, comprising four intervention clusters and four control clusters. Participants in the intervention clusters receive a six-month program of 10-hour daily time-restricted eating combined with health education and behavioral support. Participants in the control clusters continue their usual lifestyle and routine community healthcare. The same participants are assessed at baseline, three months, and six months.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)