Skip to main content
OpenTrials
Recruiting

NCT Number: 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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Singapore

Singapore, 117597

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIGHTER-MetS

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Weight

    Time frame: At baseline, 3, 6, and 12 months.

  2. Waist Circumference

    Time frame: At baseline, 3, 6, and 12 months.

  3. Blood Pressure

    Time frame: At baseline, 3, 6, and 12 months.

    Both systolic and diastolic blood pressure will be assessed.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. BMI

    Time frame: At baseline, 3, 6 and 12 month.

    Measured using InBody 120.

  14. Percentage Body Fat

    Time frame: At baseline, 3, 6 and 12 month.

    Measured using InBody 120.

  15. Body Fat Mass

    Time frame: At baseline, 3, 6 and 12 month.

    Measured using InBody 120.

  16. Visceral Fat Level

    Time frame: At baseline, 3, 6 and 12 month.

    Measured using InBody 120.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Chew

CONTACT

[email protected]

+6565168687

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Registry information

Acronym: LIGHTER-MetS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.