Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT07722338

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

Sponsor: Can Tho University of Medicine and Pharmacy

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Community-Based Time-Restricted Eating and Health Education Among Adults With Stage 1-2 Cardiovascular-Kidney-Metabolic Syndrome Without an Indication for Pharmacotherapy in Can Tho City

Key Details

Gender

All

Age Range

30 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-05-01

Completion Date

2026-11-30

Last Updated

2026-07-23

Healthy Volunteers

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.

Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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 Exclusion Criteria: Individuals with cardiovascular-kidney-metabolic syndrome stage 0, stage 3, or stage 4, or those with stage 1 or stage 2 who have a current physician-determined indication for pharmacological treatment according to applicable clinical guidelines, are excluded.

Locations (1)

Can Tho University of Madicine and Pharmacy

Can Tho, Can Tho City, Vietnam