Effectiveness and Implementation of a Community-based Health Coach-led Artificial Intelligence (AI)-Powered Digital Self-Regulation Program for Individuals With Metabolic Syndrome (MetS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNational University Health System, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are between 21 to 65 years of age;

have a waist circumference ≥90 cm in men and ≥80 cm in women;

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: LIGHTER-MetSExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline, 3, 6, and 12 months.
2

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.

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

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

Both systolic and diastolic blood pressure will be assessed.

Time frame
At baseline, 3, 6, and 12 months.
4

Three Factor Eating Questionnaire (TFEQ)

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.

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

Other outcomes

Sponsors and contacts

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