CKMCKMNCT07722338
Community-Based Time-Restricted Eating and Health Education for Adults With Stage 1-2 Cardiovascular-Kidney-Metabolic Syndrome in Can Tho City
A study testing 10-Hour Time-Restricted Eating With Health Education and Behavioral Support in people with CKM, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- CKM
- What is being tested?
- 10-Hour Time-Restricted Eating With Health Education and Behavioral Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 1 May 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Can Tho University of Madicine and Pharmacy
Can Tho, Can Tho City, 900000
About this study
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
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.
Read the detailed description
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.
PARTICIPANTS: Participants are recruited from individuals who completed the preceding community-based cross-sectional assessment of cardiovascular-kidney-metabolic syndrome and are eligible for the intervention phase. The same participants are followed throughout the study. Data are collected at three time points:
T0: baseline assessment before intervention initiation; T1: interim assessment at three months; T2: final assessment at six months. This design is intended to measure within-participant changes over time and to compare changes between the intervention and control groups.
SIX-MONTH INTERVENTION: The intervention group receives a combined program consisting of 10-hour time-restricted eating, health education, and behavioral support. The intervention is delivered continuously for six months.
- Phase 1 - Initiation and adaptation, weeks 1-2:
Participants select a fixed 10-hour daily eating window, preferably during daytime hours and compatible with their usual routine.
All energy-containing foods and beverages must be consumed within the registered eating window.
Outside the eating window, participants may consume only water or non-caloric beverages according to study instructions.
Participants are trained to identify caloric beverages, record the time of their first and last daily caloric intake, and manage common situations such as early hunger, changes in work schedules, family events, or eating outside the home.
The research team provides support to modify the eating window when necessary, and any modification is documented in the intervention record.
- Phase 2 - Maintenance and behavioral support, week 3 through month 6:
Participants continue the 10-hour daily eating window. Formal calorie counting and mandatory caloric restriction are not required. Participants are encouraged to avoid compensatory overeating and to maintain dietary practices that support cardiovascular, kidney, and metabolic health.
Educational content addresses CKM awareness, healthy diet, physical activity, weight management, tobacco and alcohol risk reduction, adequate sleep, recognition of warning symptoms, and long-term self-management.
Support is delivered through in-person counseling, small-group sessions, telephone calls, printed materials, and Zalo-based communication.
Participants are contacted during weeks 1 and 2, weekly during weeks 3 and 4, every two weeks during month 2, and are assessed in person at months 3 and 6.
During follow-up contacts, the study team records the first and last caloric intake, the number of adherent days, implementation difficulties, changes in health status, and any adverse symptoms.
A day is classified as adherent when all energy-containing foods and beverages are consumed within the participant's registered 10-hour eating window. Good adherence is defined as following the prescribed eating window on at least five days per week or on at least 80% of monitored days.
CONTROL GROUP: Participants in the control group continue their usual diet, daily activities, and routine community healthcare. They do not receive structured 10-hour time-restricted eating instructions, time-restricted eating monitoring diaries, or the intervention-specific behavioral support program. Control participants are assessed at T0, T1, and T2 using the same procedures and instruments as the intervention group.
SAFETY MONITORING: Participants are monitored throughout the intervention for tolerability and clinically relevant symptoms. If marked fatigue, dizziness, suspected hypoglycemia, or another concerning symptom occurs, the participant is advised to temporarily discontinue time-restricted eating and contact a healthcare provider. Participants who develop an indication for medication or specialist management are referred to an appropriate healthcare facility. The study intervention is not intended to replace medical evaluation, diagnosis, or physician-directed treatment.
ANALYSIS: The primary analysis follows the intention-to-treat principle, with participants analyzed according to their initially allocated cluster. Intervention effects are estimated using a Difference-in-Differences approach through the interaction between study group and time. The interaction term represents the change in the intervention group beyond the concurrent change observed in the control group.
Models appropriate for binary and continuous outcomes are used and adjusted for relevant baseline characteristics. The analysis accounts for the clustering of participants within residential areas. Additional per-protocol and adherence-based analyses are conducted to assess the consistency of the findings.
- Conditions
- CKM
- Being tested
- 10-Hour Time-Restricted Eating With Health Education and Behavioral Support
- Keywords
- Cardiovascular-Kidney-Metabolic Syndrome, Time-Restricted Feeding, Health Education
- Medical subject headings
- Intermittent Fasting, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-Hour Time-Restricted Eating With Health Education and Behavioral SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From intervention initiation to 3 months and 6 months
Secondary outcomes (3)
Physical activity
Physical activity is assessed using the International Physical Activity Questionnaire-Short Form, which records walking, moderate-intensity activity, vigorous-intensity activity, and sedentary time during the previous 7 days. Total physical activity is calculated in metabolic equivalent task minutes per week using the following coefficients: walking, 3.3 metabolic equivalents; moderate-intensity activity, 4.0 metabolic equivalents; and vigorous-intensity activity, 8.0 metabolic equivalents. Total metabolic equivalent task minutes per week are calculated by summing the walking, moderate-intensity, and vigorous-intensity components. Higher values indicate a higher level of physical activity. Change is calculated as the follow-up value minus the baseline value; a positive change indicates increased physical activity.
Measured: Baseline, 3 months, and 6 months
Change in Healthy Eating Score Measured by the Rapid Eating Assessment for Participants-Shortened Version, Version 2
Eating habits are assessed using the Rapid Eating Assessment for Participants-Shortened Version, Version 2. The total dietary behavior score is calculated from 20 items, B1 through B20, with a maximum score of 60 points. Higher scores indicate healthier eating habits and lifestyle-related dietary behaviors. Item B21 assesses readiness to change eating behavior and is analyzed separately; it is not included in the total score. Change in dietary behavior is calculated as the follow-up total score minus the baseline total score. A positive change indicates improvement in eating habits.
Measured: Baseline, 3 months, and 6 months
Change in Alcohol Use Risk Score Measured by the Alcohol Use Disorders Identification Test
Alcohol use is assessed using the 10-item Alcohol Use Disorders Identification Test. Each item is scored according to the standard scoring algorithm, producing a total score from 0 to 40. Higher scores indicate a greater level of hazardous or harmful alcohol use and a higher likelihood of alcohol-related problems. Change is calculated as the follow-up score minus the baseline score. A negative change indicates reduced alcohol-related risk.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722338
- Sponsor's protocol ID
- NIHE IRB - 36/2025
- Acronym
- CKM
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared or provided to external researchers because the study consent and local ethics approval do not include secondary data sharing. Participant-level data will be securely stored and accessed only by authorized study personnel in accordance with institutional policies and applicable ethical and data-protection requirements. Only aggregated, non-identifiable study results will be disseminated through scientific publications, conference presentations, and research reports.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07722338
- Acronym / sponsor ID
- CKM / NIHE IRB - 36/2025
- Conditions
- CKM
- Keywords
- Cardiovascular-Kidney-Metabolic Syndrome, Time-Restricted Feeding, Health Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
PARTICIPANTS: Participants are recruited from individuals who completed the preceding community-based cross-sectional assessment of cardiovascular-kidney-metabolic syndrome and are eligible for the intervention phase. The same participants are followed throughout the study. Data are collected at three time points:
T0: baseline assessment before intervention initiation; T1: interim assessment at three months; T2: final assessment at six months. This design is intended to measure within-participant changes over time and to compare changes between the intervention and control groups.
SIX-MONTH INTERVENTION: The intervention group receives a combined program consisting of 10-hour time-restricted eating, health education, and behavioral support. The intervention is delivered continuously for six months.
- Phase 1 - Initiation and adaptation, weeks 1-2:
Participants select a fixed 10-hour daily eating window, preferably during daytime hours and compatible with their usual routine.
All energy-containing foods and beverages must be consumed within the registered eating window.
Outside the eating window, participants may consume only water or non-caloric beverages according to study instructions.
Participants are trained to identify caloric beverages, record the time of their first and last daily caloric intake, and manage common situations such as early hunger, changes in work schedules, family events, or eating outside the home.
The research team provides support to modify the eating window when necessary, and any modification is documented in the intervention record.
- Phase 2 - Maintenance and behavioral support, week 3 through month 6:
Participants continue the 10-hour daily eating window. Formal calorie counting and mandatory caloric restriction are not required. Participants are encouraged to avoid compensatory overeating and to maintain dietary practices that support cardiovascular, kidney, and metabolic health.
Educational content addresses CKM awareness, healthy diet, physical activity, weight management, tobacco and alcohol risk reduction, adequate sleep, recognition of warning symptoms, and long-term self-management.
Support is delivered through in-person counseling, small-group sessions, telephone calls, printed materials, and Zalo-based communication.
Participants are contacted during weeks 1 and 2, weekly during weeks 3 and 4, every two weeks during month 2, and are assessed in person at months 3 and 6.
During follow-up contacts, the study team records the first and last caloric intake, the number of adherent days, implementation difficulties, changes in health status, and any adverse symptoms.
A day is classified as adherent when all energy-containing foods and beverages are consumed within the participant's registered 10-hour eating window. Good adherence is defined as following the prescribed eating window on at least five days per week or on at least 80% of monitored days.
CONTROL GROUP: Participants in the control group continue their usual diet, daily activities, and routine community healthcare. They do not receive structured 10-hour time-restricted eating instructions, time-restricted eating monitoring diaries, or the intervention-specific behavioral support program. Control participants are assessed at T0, T1, and T2 using the same procedures and instruments as the intervention group.
SAFETY MONITORING: Participants are monitored throughout the intervention for tolerability and clinically relevant symptoms. If marked fatigue, dizziness, suspected hypoglycemia, or another concerning symptom occurs, the participant is advised to temporarily discontinue time-restricted eating and contact a healthcare provider. Participants who develop an indication for medication or specialist management are referred to an appropriate healthcare facility. The study intervention is not intended to replace medical evaluation, diagnosis, or physician-directed treatment.
ANALYSIS: The primary analysis follows the intention-to-treat principle, with participants analyzed according to their initially allocated cluster. Intervention effects are estimated using a Difference-in-Differences approach through the interaction between study group and time. The interaction term represents the change in the intervention group beyond the concurrent change observed in the control group.
Models appropriate for binary and continuous outcomes are used and adjusted for relevant baseline characteristics. The analysis accounts for the clustering of participants within residential areas. Additional per-protocol and adherence-based analyses are conducted to assess the consistency of the findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 10-Hour Time-Restricted Eating and Behavioral Support | Experimental | Behavioral: 10-Hour Time-Restricted Eating With Health Education and Behavioral SupportParticipants 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. |
| 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. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-Hour Time-Restricted Eating With Health Education and Behavioral SupportParticipants 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. | Behavioural | 10-Hour Time-Restricted Eating and Behavioral Support |
Primary outcome
Proportion of Participants With Improvement of at Least One CKM Stage
Time frame: 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
Time frame: 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.
3 secondary outcomes
Physical activity
Time frame: Baseline, 3 months, and 6 months
Change in Healthy Eating Score Measured by the Rapid Eating Assessment for Participants-Shortened Version, Version 2
Time frame: Baseline, 3 months, and 6 months
Change in Alcohol Use Risk Score Measured by the Alcohol Use Disorders Identification Test
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared or provided to external researchers because the study consent and local ethics approval do not include secondary data sharing. Participant-level data will be securely stored and accessed only by authorized study personnel in accordance with institutional policies and applicable ethical and data-protection requirements. Only aggregated, non-identifiable study results will be disseminated through scientific publications, conference presentations, and research reports.
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RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
RecruitingObservational study
Healthy Living BEYOND Weight Study
Overweight or Obesity
Not yet recruitingEarly Phase 1
Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)
Hypertension (HTN), Diabetes (DM)
Enrolling by invitation
RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
Chronic Kidney Disease, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-Hour Time-Restricted Eating With Health Education and Behavioral Support in people with CKM, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Improvement of at Least One CKM Stage (time frame: Baseline and 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.