Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)

Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)

The primary objective of the Personalized Responses & Integrated Systems for Metabolism (PRISM-I) pilot study is to assess the feasibility of conducting a definitive randomized controlled trial evaluating precision lifestyle interventions for improving insulin resistance in adults with metabolic syndrome.

Specific objectives are to:

1. Evaluate the feasibility and acceptability of the PRISM intervention and study procedures, including participant recruitment, retention, adherence, intervention delivery, and digital platform usability.
2. Explore the preliminary effects of the four lifestyle interventions (time-restricted eating, increased physical activity, low-glycaemic load diet, and sleep hygiene) on insulin resistance, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
3. Examine the preliminary effects of the interventions on biochemical, anthropometric, behavioural, cognitive, and psychological outcomes.
4. Explore the potential behavioural and physiological pathways through which the lifestyle interventions may influence insulin resistance to inform the design of the definitive PRISM trial.

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.