Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-restricted eating, Physical Activity, Low Glycemic Load diet, Sleep hygiene.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome (MetS). Basic parameters: 21 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Interventions
- Behavioral Time-restricted eating
Following a 2-week baseline assessment, participants will begin a time-restricted eating (TRE) intervention by consuming all meals within a self-selected 8-hour eating window and fasting for the remaining 16 hours each day. They will measure blood ketone levels daily before breaking their fast using a glucometer. At Week 6, participants will be randomly assigned an additional lifestyle intervention (physical activity, low glycemic load diet, or sleep hygiene). - Behavioral Physical Activity
Following a 2-week baseline assessment, participants will begin a physical activity intervention. They will be instructed to complete home-based resistance training three times per week and aerobic interval training twice per week using a guided exercise programme. Exercise sessions will be performed independently without direct supervision. Participants will also be encouraged to aim for at least 8,000 steps daily, take a 15-minute walk after lunch and dinner where feasible, and break up prolon - Behavioral Low Glycemic Load diet
Following a 2-week baseline assessment, participants will begin a low-glycaemic load (GL) diet intervention. They will be instructed to replace high-GL foods with lower-GL alternatives, reduce their intake of refined carbohydrates, sugary foods and beverages, and ultra-processed foods, and follow healthy meal composition and meal sequencing principles. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, physical activity, or sleep hygie - Behavioral Sleep hygiene
Following a 2-week baseline assessment, participants will begin a sleep hygiene intervention. They will be instructed to adopt healthy sleep habits, including maintaining a regular sleep schedule with adequate sleep duration, practicing good bedtime routines, and optimizing the sleep environment to improve sleep quality. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, physical activity, or a low-glycemic load diet).
Primary outcome measures
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: At baseline, Week 10]
Secondary outcome measures (12)
- Glycated haemoglobin (HbA1c) (%) [Time frame: At baseline, Week 10]
- Fasting plasma glucose (mmol/L) [Time frame: At baseline, Week 10]
- Fasting Insulin (µIU/mL) [Time frame: At baseline, Week 10]
- Total cholesterol (mmol/L) [Time frame: At baseline, Week 10]
- High-density lipoprotein cholesterol (HDL-C) (mmol/L) [Time frame: At baseline, Week 10]
- Low-density lipoprotein cholesterol (LDL-C) (mmol/L) [Time frame: At baseline, Week 10]
- Cholesterol/HDL ratio [Time frame: At baseline, Week 10]
- Triglycerides (mmol/L) [Time frame: At baseline, Week 10]
- Lipoprotein a (nmol/L) [Time frame: At baseline, Week 10]
- Apolipoprotein A1 (g/L) [Time frame: At baseline, Week 10]
- Apolipoprotein B (g/L) [Time frame: At baseline, Week 10]
- Apolipoprotein B/ A1 ratio [Time frame: At baseline, Week 10]
Eligibility criteria
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.
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: NCT07710274 · NUS-IRB-2026-0409