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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Improvement of at Least One CKM Stage
研究概览
简要总结
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.
详细描述
This study uses a controlled community-based intervention design with cluster allocation by drawing lots, with longitudinal follow-up and repeated measurements in the same participants. The unit of allocation is the residential-area cluster within each ward or commune, while study outcomes are assessed at the individual level.
CLUSTER ALLOCATION: The intervention phase is implemented in four administrative study sites that previously participated in the community-based CKM survey, including two urban wards and two rural communes in Can Tho City, Viet Nam. Within each administrative site, two geographically separate residential areas are selected. One area is allocated to the intervention condition and the other to the control condition by drawing lots, without discretionary assignment by the investigators. Cluster allocation is used to reduce contamination between study groups and to facilitate community-level implementation.
The study areas are allocated as follows:
- Phong Dien Commune: the intervention area is Giai Xuan, a former administrative unit now incorporated into Phong Dien Commune; the control area is Phong Dien.
- Truong Long Tay Commune: the intervention area is Truong Long Tay; the control area is Truong Long A, a former administrative unit now incorporated into Truong Long Tay Commune.
- O Mon Ward: the intervention area is Thoi An, a former administrative unit now incorporated into O Mon Ward; the control area is O Mon.
- Phuoc Thoi Ward: the intervention area is Phuoc Thoi; the control area is Truong Lac, a former administrative unit now incorporated into Phuoc Thoi Ward.
The study therefore includes four intervention clusters and four control clusters. Allocation occurs at the residential-area level rather than at the individual level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Proportion of Participants With Improvement of at Least One CKM Stage
时间窗: Baseline and 3 months, 6 months
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.
Adherence to 10-Hour Time-Restricted Eating
时间窗: From intervention initiation to 3 months and 6 months
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.
次要结局
- 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)