Personalized Living Plan to Improve Metabolic Health in Adults with Metabolic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRISM-I pilot study aims to determine whether a precision lifestyle program is feasible for adults with metabolic syndrome and insulin resistance. It will evaluate recruitment, retention, adherence, and the usability of a digital platform used to deliver four lifestyle interventions: time-restricted eating, increased physical activity, a low-glycemic load diet, and sleep hygiene. The study will also explore preliminary effects on insulin resistance (HOMA-IR) and a range of biochemical, anthropometric, behavioral, cognitive, and psychological outcomes to inform a larger definitive trial. Findings will help identify behavioral and physiological pathways through which these interventions might improve insulin resistance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants will be included for if they are:

* (1) adults aged 21-70 years old;
* (2) willing and able to comply with using a CGM, smart ring, food logging app
* (3) able to provide written informed consent;
* (4) English-speaking and literate;
* (5) meet the inclusion criteria for metabolic syndrome and insulin resistance.
* The criteria for insulin resistance is HOMA-IR ≥ 2.5.
* The criteria for metabolic syndrome is to have high waist circumference (≥ 80cm for females and ≥ 90cm for males); and any two of the four below:
* (1) raised triglycerides: 1.7 mmol/L or on treatment;
* (2) reduced HDL cholesterol: \< 1.0 mmol/L (40 mg/dL) in men, \< 1.3 mmol/L (50 mg/dL) in women, or on treatment;
* (3) high blood pressure: 130/85 mmHg or on treatment; or
* (4) raised fasting glucose: 5.6 mmol/L (100 mg/dL) or previously diagnosed with T2DM

Exclusion Criteria:

Participants will be excluded from both phases if they are:

* (1) on insulin therapy;
* (2) are pregnant or lactating;
* (3) have a medical condition or are on a treatment that may interfere with study participation or metabolic assessments, as determined by the study investigators;
* (4) currently participating in other lifestyle modification programs.

Where it's running

• National University of Singapore
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Jocelyn Chew
• Email: dbi-lab@nus.edu.sg
• Phone: +6565168687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.