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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. are between 21 to 65 years of age;
  2. have a waist circumference ≥90 cm in men and ≥80 cm in women;

  3. 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;
  4. are not receiving other structured lifestyle modification programs;
  5. consent to audio-recording;
  6. English speaking and literate.

Exclusion Criteria:

  1. underwent or are scheduled for metabolic surgery within 1 year;
  2. are pregnant or planning for pregnancy at the time of recruitment;
  3. are unable to speak English;
  4. do not own a smartphone; and
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Health System, Singapore

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings