- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410325
Effectiveness and Implementation of a Community-based Health Coach-led Artificial Intelligence (AI)-Powered Digital Self-Regulation Program for Individuals With Metabolic Syndrome (MetS) (LIGHTER-MetS)
April 7, 2026 updated by: Jocelyn Chew, National University Health System, Singapore
This study aims to evaluate the effectiveness of the Lifestyle Intervention for Gentle, Healthy Transformation and Enhanced Weight Reduction-metabolic syndrome (LIGHTER-MetS) program on dietary self-regulation and cardiovascular risk among individuals with metabolic syndrome (MetS).
The LIGHTER-MetS program, a community-based, grassroots-led initiative, integrates health coaching with the eTRIP© app to promote sustainable lifestyle changes focusing on diet, exercise, and emotion regulation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
316
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jocelyn Chew
- Phone Number: +6565168687
- Email: dbi-lab@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 117597
- Recruiting
- National University of Singapore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- are between 21 to 65 years of age;
- have a waist circumference ≥90 cm in men and ≥80 cm in women;
have 2 or more of the following to be classified as having metabolic syndrome:
- triglyceride level of ≥1.7 mmol/L or on specific treatment for this lipid abnormality;
- high density lipoprotein (HDL) cholesterol <1.03 mmol/L in men, and <1.29 mmol/L in women, or on specific treatment for this lipid abnormality;
- blood pressure of ≥130/85 mmHg or on treatment of previously diagnosed hypertension;
- fasting blood glucose level of ≥ 5.6 mmol/L or previously diagnosed type 2 diabetes;
- are not receiving other structured lifestyle modification programs;
- consent to audio-recording;
- English speaking and literate.
Exclusion Criteria:
- underwent or are scheduled for metabolic surgery within 1 year;
- are pregnant or planning for pregnancy at the time of recruitment;
- are unable to speak English;
- do not own a smartphone; and
- are unable to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LIGHTER-MetS
The LIGHTER-MetS program includes community-based health coaching by the PI or a trained healthcare professional (e.g.
nurse, physiotherapist etc.) at baseline visit and for 3 months following the baseline visit.
Throughout the first 3 months, participants will also use the eTRIP© app to log meals, monitor physical activity, and receive personalized feedback.
During the 3-month intervention period, there will be one-to-one slots for the health coach to follow up on participants' health plan.
|
The LIGHTER-MetS program includes community-based health coaching by the PI or a trained healthcare professional (e.g.
nurse, physiotherapist etc.) at baseline visit and for 3 months following the baseline visit.
Throughout the first 3 months, participants will also use the eTRIP© app to log meals, monitor physical activity, and receive personalized feedback.
During the 3-month intervention period, there will be one-to-one slots for the health coach to follow up on participants' health plan.
|
|
No Intervention: Control
Participants will receive personalised health plans provided as part of usual care when they see a family physician.
As part of the HealthierSG initiative, health plans are typically formulated to target early disease prevention and chronic condition management through history taking, physical examination, appropriate diagnostic testing, treatment, referrals and lifestyle modification goals and activity planning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self regulation of Eating Behaviour Questionnaire (SREBQ)
Time Frame: At baseline, 3, 6, and 12 months.
|
The Self-Regulation of Eating Behaviour Questionnaire (SREBQ) is a validated self-administered instrument used to assess individuals' self-regulation in relation to eating behavior.
It evaluates the extent to which individuals monitor, control, and regulate their eating behaviors in everyday contexts.
Higher scores indicate greater self-regulation of eating behavior.
|
At baseline, 3, 6, and 12 months.
|
|
Cardiovascular Risk
Time Frame: At baseline, 3, 6, and 12 months.
|
Cardiovascular risk will be assessed via the ASCVD-risk calculator and the Singapore-modified Framingham Risk Score 2023 (SG-FRS-2023).
Higher scores indicate a greater estimated cardiovascular risk.
|
At baseline, 3, 6, and 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: At baseline, 3, 6, and 12 months.
|
At baseline, 3, 6, and 12 months.
|
|
|
Waist Circumference
Time Frame: At baseline, 3, 6, and 12 months.
|
At baseline, 3, 6, and 12 months.
|
|
|
Blood Pressure
Time Frame: At baseline, 3, 6, and 12 months.
|
Both systolic and diastolic blood pressure will be assessed.
|
At baseline, 3, 6, and 12 months.
|
|
Three Factor Eating Questionnaire (TFEQ)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Three-Factor Eating Questionnaire (TFEQ) is a validated self-administered instrument used to assess eating-related behaviors.
It measures three domains: cognitive restraint of eating, uncontrolled eating, and emotional eating.
Higher scores indicate greater levels of the respective eating behavior.
|
At baseline, 3, 6 and 12 month.
|
|
Consideration of Future Consequences Scale (CFCS-6)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Consideration of Future Consequences Scale - 6 item (CFCS-6) is a validated self-administered questionnaire used to assess the extent to which individuals consider the potential future outcomes of their current behaviors.
It evaluates the degree to which individuals weigh immediate versus future consequences when making decisions.
Higher scores indicate greater consideration of future consequences.
|
At baseline, 3, 6 and 12 month.
|
|
Self-Report Behavioural Automaticity Index (SRBAI)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Self-Report Behavioural Automaticity Index (SRBAI) is a validated self-administered questionnaire used to assess the automaticity of behavior.
It evaluates the extent to which a behavior is performed automatically, with little conscious thought or deliberation.
Higher scores indicate greater behavioral automaticity.
|
At baseline, 3, 6 and 12 month.
|
|
International Physical Activity Questionnaire Short-Form (IPAQ-SF)
Time Frame: At baseline, 3, 6 and 12 month.
|
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated self-administered questionnaire used to assess self-reported physical activity levels.
It captures the frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity performed over the past 7 days.
|
At baseline, 3, 6 and 12 month.
|
|
Generalized Anxiety Disorder 2-item (GAD-2)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Generalized Anxiety Disorder - 2 item (GAD-2) is a validated self-administered screening questionnaire used to assess the frequency of core anxiety symptoms over the past two weeks.
Higher scores indicate greater anxiety symptom severity.
|
At baseline, 3, 6 and 12 month.
|
|
Patient Health Questionnaire-2 (PHQ-2)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Patient Health Questionnaire - 2 item (PHQ-2) is a validated self-administered screening questionnaire used to assess the frequency of depressive symptoms over the past two weeks.
Higher scores indicate greater depressive symptom severity.
|
At baseline, 3, 6 and 12 month.
|
|
Perceived Stress Scale (PSS-10)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Perceived Stress Scale - 10 item (PSS-10) is a validated self-administered questionnaire used to assess perceived stress levels over the past month.
It measures the extent to which individuals perceive situations in their lives as stressful.
Higher scores indicate greater perceived stress.
|
At baseline, 3, 6 and 12 month.
|
|
Euro Quality of life 5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame: At baseline, 3, 6 and 12 month.
|
The EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) is a standardized self-administered instrument used to assess health-related quality of life.
It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels.
|
At baseline, 3, 6 and 12 month.
|
|
Big Five Inventory - 44 item (BFI-44)
Time Frame: At baseline, 3, 6 and 12 month.
|
The Big Five Inventory - 44 item (BFI-44) is a validated self-administered questionnaire used to assess personality traits across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism.
Higher scores indicate greater expression of the respective personality traits.
|
At baseline, 3, 6 and 12 month.
|
|
BMI
Time Frame: At baseline, 3, 6 and 12 month.
|
Measured using InBody 120.
|
At baseline, 3, 6 and 12 month.
|
|
Percentage Body Fat
Time Frame: At baseline, 3, 6 and 12 month.
|
Measured using InBody 120.
|
At baseline, 3, 6 and 12 month.
|
|
Body Fat Mass
Time Frame: At baseline, 3, 6 and 12 month.
|
Measured using InBody 120.
|
At baseline, 3, 6 and 12 month.
|
|
Visceral Fat Level
Time Frame: At baseline, 3, 6 and 12 month.
|
Measured using InBody 120.
|
At baseline, 3, 6 and 12 month.
|
|
Homeostatic Model Assessment of Insulin Resistance
Time Frame: At baseline, 3 and 12 months.
|
Measured using (fasting blood insulin X fasting blood glucose)/22.5.
|
At baseline, 3 and 12 months.
|
|
Fasting Blood Glucose (mmol/L)
Time Frame: At baseline, 3, 6 and 12 month.
|
Fasting blood glucose is a biochemical measure of blood glucose concentration after an overnight fast, measured using standard laboratory blood analysis.
Higher values indicate poorer glycaemic control.
|
At baseline, 3, 6 and 12 month.
|
|
Glycated haemoglobin (HbA1c) (%)
Time Frame: At baseline, 3, 6 and 12 month.
|
Glycated haemoglobin (HbA1c) reflects average blood glucose levels over the preceding two to three months and is measured using standard laboratory blood analysis.
Higher values indicate poorer long-term glycaemic control.
|
At baseline, 3, 6 and 12 month.
|
|
Triglycerides (mmol/L)
Time Frame: At baseline, 3, 6 and 12 month
|
Triglycerides are a lipid biomarker measured using standard laboratory blood analysis to assess circulating triglyceride levels.
Higher values indicate poorer lipid profiles and increased cardiometabolic risk.
|
At baseline, 3, 6 and 12 month
|
|
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
Time Frame: At baseline, 3, 6 and 12 month.
|
High-density lipoprotein cholesterol (HDL-C) is a lipid biomarker measured using standard laboratory blood analysis to assess protective cholesterol levels.
Lower values indicate poorer lipid profiles and increased cardiometabolic risk.
|
At baseline, 3, 6 and 12 month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
June 24, 2025
First Submitted That Met QC Criteria
February 7, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2024-866
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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