Overview
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.
Description
Specific objectives are to:
- Evaluate the feasibility and acceptability of the PRISM intervention and study procedures, including participant recruitment, retention, adherence, intervention delivery, and digital platform usability.
- 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).
- Examine the preliminary effects of the interventions on biochemical, anthropometric, behavioural, cognitive, and psychological outcomes.
- 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.
Eligibility
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.
