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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Self regulation of Eating Behaviour Questionnaire (SREBQ) [Time frame: At baseline, 3, 6, and 12 months.]
• Cardiovascular Risk [Time frame: At baseline, 3, 6, and 12 months.]

Secondary outcome measures (12)

• Weight [Time frame: At baseline, 3, 6, and 12 months.]
• Waist Circumference [Time frame: At baseline, 3, 6, and 12 months.]
• Blood Pressure [Time frame: At baseline, 3, 6, and 12 months.]
• Three Factor Eating Questionnaire (TFEQ) [Time frame: At baseline, 3, 6 and 12 month.]
• Consideration of Future Consequences Scale (CFCS-6) [Time frame: At baseline, 3, 6 and 12 month.]
• Self-Report Behavioural Automaticity Index (SRBAI) [Time frame: At baseline, 3, 6 and 12 month.]
• International Physical Activity Questionnaire Short-Form (IPAQ-SF) [Time frame: At baseline, 3, 6 and 12 month.]
• Generalized Anxiety Disorder 2-item (GAD-2) [Time frame: At baseline, 3, 6 and 12 month.]
• Patient Health Questionnaire-2 (PHQ-2) [Time frame: At baseline, 3, 6 and 12 month.]
• Perceived Stress Scale (PSS-10) [Time frame: 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.]
• Big Five Inventory - 44 item (BFI-44) [Time frame: At baseline, 3, 6 and 12 month.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Singapore · 1 center

• National University of Singapore — Singapore

Identifiers

NCT: NCT07410325 · NUS-IRB-2024-866

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗