NCT07410325

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

June 24, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 24, 2025

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self regulation of Eating Behaviour Questionnaire (SREBQ)

    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

    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 Outcomes (21)

  • Weight

    At baseline, 3, 6, and 12 months.

  • Waist Circumference

    At baseline, 3, 6, and 12 months.

  • Blood Pressure

    At baseline, 3, 6, and 12 months.

  • Three Factor Eating Questionnaire (TFEQ)

    At baseline, 3, 6 and 12 month.

  • Consideration of Future Consequences Scale (CFCS-6)

    At baseline, 3, 6 and 12 month.

  • +16 more secondary outcomes

Study Arms (2)

LIGHTER-MetS

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

LIGHTER-MetSBEHAVIORAL

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.

LIGHTER-MetS

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, 117597, Singapore

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

February 13, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations