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NCT Number: NCT07710274

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Singapore

Singapore, 117597

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time-restricted eating

Behavioral

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).

Physical activity

Behavioral

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 prolonged sitting every 30-60 minutes with light movement or standing. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, low-glycemic load diet, or sleep hygiene).

Low Glycemic Load diet

Behavioral

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 hygiene).

Sleep Hygiene

Behavioral

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 outcomes

  1. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: At baseline, Week 10

    Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as:

    HOMA-IR = (fasting plasma insulin × fasting plasma glucose) / 22.5

    Higher HOMA-IR values indicate greater insulin resistance, whereas lower values indicate improved insulin sensitivity (reduced insulin resistance).

Secondary outcomes

  1. Glycated haemoglobin (HbA1c) (%)

    Time frame: At baseline, Week 10

    Glycated haemoglobin (HbA1c) reflects average blood glucose levels over the preceding two to three months and is measured using standard laboratory blood analysis. Higher values indicate poorer long-term glycaemic control.

  2. Fasting plasma glucose (mmol/L)

    Time frame: At baseline, Week 10

    Fasting blood glucose is a biochemical measure of blood glucose concentration after an overnight fast, measured using standard laboratory blood analysis. Higher values indicate poorer glycaemic control.

  3. Fasting Insulin (µIU/mL)

    Time frame: At baseline, Week 10

    Fasting plasma insulin is a biochemical marker measured using standard laboratory blood analysis following an overnight fast. Higher values indicate greater insulin resistance and impaired glucose metabolism.

  4. Total cholesterol (mmol/L)

    Time frame: At baseline, Week 10

    Total cholesterol is a lipid biomarker measured using standard laboratory blood analysis to assess overall blood cholesterol levels. Higher values indicate poorer lipid profiles and increased cardiometabolic risk.

  5. High-density lipoprotein cholesterol (HDL-C) (mmol/L)

    Time frame: At baseline, Week 10

    High-density lipoprotein cholesterol (HDL-C) is a lipid biomarker measured using standard laboratory blood analysis to assess protective cholesterol levels. Lower values indicate poorer lipid profiles and increased cardiometabolic risk.

  6. Low-density lipoprotein cholesterol (LDL-C) (mmol/L)

    Time frame: At baseline, Week 10

    Low-density lipoprotein cholesterol (LDL-C) is a lipid biomarker measured using standard laboratory blood analysis to assess atherogenic cholesterol levels. Higher values indicate poorer lipid profiles and increased cardiovascular risk.

  7. Cholesterol/HDL ratio

    Time frame: At baseline, Week 10

    The total cholesterol to HDL cholesterol ratio is calculated from standard laboratory blood analysis and is used to assess cardiovascular risk. Higher values indicate a poorer lipid profile and increased cardiometabolic risk.

  8. Triglycerides (mmol/L)

    Time frame: At baseline, Week 10

    Triglycerides are a lipid biomarker measured using standard laboratory blood analysis to assess circulating triglyceride levels. Higher values indicate poorer lipid profiles and increased cardiometabolic risk.

  9. Lipoprotein a (nmol/L)

    Time frame: At baseline, Week 10

    Lipoprotein(a) is an advanced lipid biomarker measured using standard laboratory blood analysis to assess inherited cardiovascular risk. Higher values are associated with increased risk of atherosclerotic cardiovascular disease

  10. Apolipoprotein A1 (g/L)

    Time frame: At baseline, Week 10

    Apolipoprotein A1 (ApoA1) is a lipid biomarker measured using standard laboratory blood analysis to assess the major protein component of HDL cholesterol. Higher values generally indicate a more favourable lipid profile.

  11. Apolipoprotein B (g/L)

    Time frame: At baseline, Week 10

    Apolipoprotein B (ApoB) is a lipid biomarker measured using standard laboratory blood analysis to assess the number of atherogenic lipoprotein particles. Higher values indicate increased cardiovascular risk.

  12. Apolipoprotein B/ A1 ratio

    Time frame: At baseline, Week 10

    The Apolipoprotein B/A1 ratio is calculated from standard laboratory blood analysis and reflects the balance between atherogenic and protective lipoproteins. Higher values indicate increased cardiovascular risk

  13. High-sensitivity C-reactive protein (hs-CRP) (mg/L)

    Time frame: At baseline, Week 10

    High-sensitivity C-reactive protein (hs-CRP) is an inflammatory biomarker measured using standard laboratory blood analysis to assess low-grade systemic inflammation. Higher values indicate greater systemic inflammation and increased cardiometabolic risk.

  14. Total protein (g/L)

    Time frame: At baseline, Week 10

    Total protein is measured using standard laboratory blood analysis to assess the combined concentration of albumin and globulins in blood.

  15. Albumin (g/L)

    Time frame: At baseline, Week 10

    Albumin is a plasma protein measured using standard laboratory blood analysis to assess nutritional status and liver function. Lower values may indicate impaired liver function, malnutrition, or inflammation.

  16. Globulin (g/L)

    Time frame: At baseline, Week 10

    Globulin is measured using standard laboratory blood analysis to assess immune and inflammatory proteins in the blood.

  17. A/G ratio

    Time frame: At baseline, Week 10

    The albumin-to-globulin (A/G) ratio is calculated from serum albumin and globulin concentrations and is used to assess liver function, nutritional status, and inflammatory conditions.

  18. Bilirubin (µmol/L)

    Time frame: At baseline, Week 10

    Bilirubin is measured using standard laboratory blood analysis to assess liver function and bilirubin metabolism.

  19. Alkaline phosphatase (ALP) (U/L)

    Time frame: At baseline, Week 10

    Alkaline phosphatase (ALP) is a liver enzyme measured using standard laboratory blood analysis to assess liver and biliary tract function.

  20. Alanine aminotransferase (ALT/SGPT) (U/L)

    Time frame: At baseline, Week 10

    Alanine aminotransferase (ALT/SGPT) is a liver enzyme measured using standard laboratory blood analysis to assess liver cell injury.

  21. Aspartate aminotransferase (AST/SGOT) (U/L)

    Time frame: At baseline, Week 10

    Aspartate aminotransferase (AST/SGOT) is a liver enzyme measured using standard laboratory blood analysis to assess liver and muscle cell injury. Higher values may indicate liver damage or other tissue injury.

  22. Blood pressure (mmHg)

    Time frame: At baseline, Week 10

    Both systolic and diastolic blood pressure will be assessed.

  23. Montreal Cognitive Assessment (MoCA)

    Time frame: At baseline, Week 10

    The Montreal Cognitive Assessment is a validated screening instrument designed to detect mild cognitive impairment. It assesses multiple cognitive domains, including attention and concentration, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function.

  24. Hand grip strength (kg)

    Time frame: At baseline, Week 10

    Hand grip strength will be measured using a Jamar dynamometer as an indicator of muscle strength. Higher values indicate greater muscle strength.

  25. Weight (kg)

    Time frame: At baseline, Weeks 5,10

  26. Waist circumference (cm)

    Time frame: At baseline, Weeks 5,10

  27. Body mass index (BMI) (kg/m²)

    Time frame: At baseline, Weeks 5,10

    Body mass index (BMI) will be calculated as weight (kg)/height² (m²). Lower values indicate lower overall adiposity.

  28. Percentage Body Fat (%)

    Time frame: At baseline, Weeks 5,10

    Percentage body fat will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate lower adiposity.

  29. Body Fat Mass (kg)

    Time frame: At baseline, Weeks 5,10

    Measured using InBody 120.

  30. Visceral Fat Level

    Time frame: At baseline, Week 10

    Visceral fat level will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate reduced visceral adiposity.

  31. ABSI (body shape index)

    Time frame: At baseline, Weeks 5,10

    A Body Shape Index (ABSI) is calculated from waist circumference, height, and body weight to assess central adiposity independently of BMI. Higher values indicate greater abdominal obesity and cardiometabolic risk.

  32. BRI (body roundness index)

    Time frame: At baseline, Weeks 5,10

    Body Roundness Index (BRI) is calculated from height and waist circumference to estimate body fat distribution and central adiposity. Higher values indicate greater abdominal adiposity and cardiometabolic risk.

  33. Three Factor Eating Questionnaire (TFEQ)

    Time frame: At baseline, Week 10

    The Three-Factor Eating Questionnaire-Revised 18 is a validated self-administered instrument used to assess eating-related behaviours. It measures three domains: cognitive restraint, uncontrolled eating, and emotional eating. Scores are calculated separately for each domain and transformed to a 0-100 scale, with higher scores indicating greater levels of the respective eating behaviour.

  34. International Physical Activity Questionnaire Short-Form (IPAQ-SF)

    Time frame: At baseline, Week 10

    The International Physical Activity Questionnaire - Short Form is a validated self-administered questionnaire used to assess self-reported physical activity levels over the previous 7 days. It captures the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and time spent sitting. Responses are used to calculate total physical activity expressed as MET-minutes/week. There is no fixed minimum or maximum score; higher MET-minutes/week indicate higher levels of physical activity.

  35. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: At baseline, Week 10

    The Generalized Anxiety Disorder 7-item questionnaire is a validated self-administered screening instrument used to assess the frequency of anxiety symptoms over the previous 2 weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

  36. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: At baseline, Week 10

    The Patient Health Questionnaire-9 is a validated self-administered screening instrument used to assess the frequency of depressive symptoms over the previous 2 weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.

  37. Perceived Stress Scale (PSS-10)

    Time frame: At baseline, Week 10

    The Perceived Stress Scale-10 is a validated self-administered questionnaire used to assess the degree to which individuals perceive situations in their lives as stressful over the previous month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

  38. Big Five Inventory - 44 item (BFI-44)

    Time frame: At baseline, Week 10

    The Big Five Inventory-44 is a validated self-administered questionnaire used to assess personality across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism. Scores are calculated separately for each domain; there is no overall total score. Domain scores are typically calculated as the mean of the items within each domain and range from 1 to 5, with higher scores indicating greater expression of the respective personality trait. As this is a descriptive measure of personality, higher scores do not represent universally better or worse outcomes.

  39. Sleep Hygiene Index (SHI)

    Time frame: At baseline, Week 10

    The Sleep Hygiene Index is a validated 13-item self-administered questionnaire that assesses behaviours associated with sleep hygiene. Total scores range from 13 to 65, with higher scores indicating poorer sleep hygiene practices.

  40. Gut microbiome

    Time frame: At baseline, Week 10

  41. Resting heart rate (beats/min)

    Time frame: Baseline through Week 10

    Resting heart rate measured using the Oura Ring. Resting heart rate represents the average heart rate during periods of rest. Lower values generally indicate better cardiovascular fitness.

  42. Heart rate variability (ms)

    Time frame: Baseline through Week 10

    Heart rate variability measured using the Oura Ring. HRV reflects variation in the time interval between successive heartbeats and is an indicator of autonomic nervous system function. Higher values generally indicate better autonomic regulation and recovery.

  43. Heart rate recovery (beats/min)

    Time frame: Baseline through Week 10

    Heart rate recovery measured using the Oura Ring. Heart rate recovery represents the reduction in heart rate following physical activity and reflects cardiovascular recovery capacity. Higher values indicate faster recovery and better cardiovascular fitness.

  44. Sleep duration (hours)

    Time frame: Baseline through Week 10

    Sleep duration measured using the Oura Ring. Sleep duration represents the total amount of sleep obtained per night. Higher values generally indicate longer sleep duration.

  45. Sleep quality score (0-100)

    Time frame: Baseline through Week 10

    Sleep quality score measured using the Oura Ring. Scores range from 0 to 100, with higher scores indicating better sleep quality.

  46. Daily step count (steps/day)

    Time frame: Baseline through Week 10

    Daily step count measured using the Oura Ring. Step count represents the total number of steps accumulated per day. Higher values indicate greater daily physical activity.

  47. Activity intensity minutes (minutes/day)

    Time frame: Baseline through Week 10

    Activity intensity minutes measured using the Oura Ring. This metric represents the daily duration of moderate-to-vigorous physical activity. Higher values indicate greater participation in physical activity.

  48. Energy expenditure (kcal/day)

    Time frame: Baseline through Week 10

    Energy expenditure measured using the Oura Ring. This metric represents the estimated daily energy expenditure from physical activity. Higher values indicate greater energy expenditure.

  49. Mean glucose (mmol/L)

    Time frame: Baseline through Week 10

    Mean glucose concentration measured using continuous glucose monitoring. Mean glucose represents the average glucose concentration over the monitoring period. Lower values generally indicate better glycaemic control.

  50. Coefficient of variation (%)

    Time frame: Baseline through Week 10

    Coefficient of variation of glucose measured using continuous glucose monitoring. CV reflects glucose variability relative to mean glucose concentration. Lower values indicate more stable glucose levels and better glycaemic control.

  51. Time Below Range (TBR, %)

    Time frame: Baseline through Week 10

    Percentage of time spent below the target glucose range (<3.9 mmol/L), measured using continuous glucose monitoring. Lower values indicate less time spent in hypoglycaemia and better glycaemic control.

  52. Time In Range (TIR, %)

    Time frame: Baseline through Week 10

    Percentage of time spent within the target glucose range (3.9-10.0 mmol/L), measured using continuous glucose monitoring. Higher values indicate better glycaemic control.

  53. Time Above Range (TAR, %)

    Time frame: Baseline through Week 10

    Percentage of time spent above the target glucose range (>10.0 mmol/L), measured using continuous glucose monitoring. Lower values indicate less hyperglycaemia and better glycaemic control.

  54. Postprandial glucose excursion (PPGE) (mmol/L)

    Time frame: Baseline through Week 10

    Postprandial glucose excursion measured using continuous glucose monitoring. PPGE is calculated as the difference between peak glucose concentration and pre-meal glucose concentration within 2 hours after the start of a meal. Higher values indicate greater postprandial glucose excursions.

  55. Incremental Area Under the Curve (iAUC, mmol/L·min)

    Time frame: Baseline through Week 10

    Incremental area under the glucose curve measured using continuous glucose monitoring. iAUC represents the area under the glucose curve above the pre-meal baseline during the 2-hour period following a meal. Higher values indicate greater overall postprandial glucose exposure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Chew

CONTACT

[email protected]

+6565168687

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Registry information

Acronym: PRISM-I

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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