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

15. juli 2026 opdateret af: Jocelyn Chew, National University Health System, Singapore
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Singapore
      • Singapore, Singapore, 117597
        • National University of Singapore

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
At baseline, participants will undergo blood collection, stool sample collection, questionnaires, and cognitive and physical assessments. They will be provided with an Oura Ring and continuous glucose monitor (CGM) to monitor physiological and behavioral measures throughout the study. Participants will use the eTRIP© app to log meals and the Oura app to record physical activity. General healthy lifestyle information on diet, physical activity, and sleep will be provided at baseline. Participants assigned to the control group will continue their usual lifestyle throughout the 10-week study and will not receive any targeted lifestyle intervention. At Week 5, participants will attend a study visit for interim assessments and replacement of the CGM for the remainder of the study. Baseline assessments will be repeated at Week 10.
Eksperimentel: PRISM
At baseline, participants will undergo blood collection, stool sample collection, questionnaires, and cognitive and physical assessments. They will be provided with an Oura Ring and continuous glucose monitor (CGM) to monitor physiological and behavioural measures throughout the study. Participants will use the eTRIP© app to log meals and the Oura app to record physical activity. General healthy lifestyle advice on diet, physical activity, and sleep will be provided at baseline. At the end of the 2-week baseline assessment, participants will be randomized to one of four lifestyle interventions: time-restricted eating, increased physical activity, a low-glycemic load diet, or sleep hygiene. At Week 5, participants will attend a study visit and be randomized to receive an additional intervention from one of the remaining three lifestyle domains, beginning in Week 6. Baseline assessments will be repeated at Week 10.
Adfærdsmæssigt: 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).
Adfærdsmæssigt: 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 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).
Adfærdsmæssigt: 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 hygiene).
Adfærdsmæssigt: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: 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).
At baseline, Week 10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycated haemoglobin (HbA1c) (%)
Tidsramme: 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.
At baseline, Week 10
Fasting plasma glucose (mmol/L)
Tidsramme: 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.
At baseline, Week 10
Fasting Insulin (µIU/mL)
Tidsramme: 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.
At baseline, Week 10
Total cholesterol (mmol/L)
Tidsramme: 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.
At baseline, Week 10
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
Tidsramme: 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.
At baseline, Week 10
Low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Tidsramme: 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.
At baseline, Week 10
Cholesterol/HDL ratio
Tidsramme: 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.
At baseline, Week 10
Triglycerides (mmol/L)
Tidsramme: 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.
At baseline, Week 10
Lipoprotein a (nmol/L)
Tidsramme: 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
At baseline, Week 10
Apolipoprotein A1 (g/L)
Tidsramme: 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.
At baseline, Week 10
Apolipoprotein B (g/L)
Tidsramme: 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.
At baseline, Week 10
Apolipoprotein B/ A1 ratio
Tidsramme: 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
At baseline, Week 10
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Tidsramme: 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.
At baseline, Week 10
Total protein (g/L)
Tidsramme: At baseline, Week 10
Total protein is measured using standard laboratory blood analysis to assess the combined concentration of albumin and globulins in blood.
At baseline, Week 10
Albumin (g/L)
Tidsramme: 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.
At baseline, Week 10
Globulin (g/L)
Tidsramme: At baseline, Week 10
Globulin is measured using standard laboratory blood analysis to assess immune and inflammatory proteins in the blood.
At baseline, Week 10
A/G ratio
Tidsramme: 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.
At baseline, Week 10
Bilirubin (µmol/L)
Tidsramme: At baseline, Week 10
Bilirubin is measured using standard laboratory blood analysis to assess liver function and bilirubin metabolism.
At baseline, Week 10
Alkaline phosphatase (ALP) (U/L)
Tidsramme: At baseline, Week 10
Alkaline phosphatase (ALP) is a liver enzyme measured using standard laboratory blood analysis to assess liver and biliary tract function.
At baseline, Week 10
Alanine aminotransferase (ALT/SGPT) (U/L)
Tidsramme: At baseline, Week 10
Alanine aminotransferase (ALT/SGPT) is a liver enzyme measured using standard laboratory blood analysis to assess liver cell injury.
At baseline, Week 10
Aspartate aminotransferase (AST/SGOT) (U/L)
Tidsramme: 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.
At baseline, Week 10
Blood pressure (mmHg)
Tidsramme: At baseline, Week 10
Both systolic and diastolic blood pressure will be assessed.
At baseline, Week 10
Montreal Cognitive Assessment (MoCA)
Tidsramme: 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.
At baseline, Week 10
Hand grip strength (kg)
Tidsramme: 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.
At baseline, Week 10
Weight (kg)
Tidsramme: At baseline, Weeks 5,10
At baseline, Weeks 5,10
Waist circumference (cm)
Tidsramme: At baseline, Weeks 5,10
At baseline, Weeks 5,10
Body mass index (BMI) (kg/m²)
Tidsramme: At baseline, Weeks 5,10
Body mass index (BMI) will be calculated as weight (kg)/height² (m²). Lower values indicate lower overall adiposity.
At baseline, Weeks 5,10
Percentage Body Fat (%)
Tidsramme: At baseline, Weeks 5,10
Percentage body fat will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate lower adiposity.
At baseline, Weeks 5,10
Body Fat Mass (kg)
Tidsramme: At baseline, Weeks 5,10
Measured using InBody 120.
At baseline, Weeks 5,10
Visceral Fat Level
Tidsramme: At baseline, Week 10
Visceral fat level will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate reduced visceral adiposity.
At baseline, Week 10
ABSI (body shape index)
Tidsramme: 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.
At baseline, Weeks 5,10
BRI (body roundness index)
Tidsramme: 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.
At baseline, Weeks 5,10
Three Factor Eating Questionnaire (TFEQ)
Tidsramme: 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.
At baseline, Week 10
International Physical Activity Questionnaire Short-Form (IPAQ-SF)
Tidsramme: 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.
At baseline, Week 10
Generalized Anxiety Disorder 7-item (GAD-7)
Tidsramme: 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.
At baseline, Week 10
Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: 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.
At baseline, Week 10
Perceived Stress Scale (PSS-10)
Tidsramme: 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.
At baseline, Week 10
Big Five Inventory - 44 item (BFI-44)
Tidsramme: 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.
At baseline, Week 10
Sleep Hygiene Index (SHI)
Tidsramme: 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.
At baseline, Week 10
Gut microbiome
Tidsramme: At baseline, Week 10
At baseline, Week 10
Resting heart rate (beats/min)
Tidsramme: 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.
Baseline through Week 10
Heart rate variability (ms)
Tidsramme: 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.
Baseline through Week 10
Heart rate recovery (beats/min)
Tidsramme: 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.
Baseline through Week 10
Sleep duration (hours)
Tidsramme: 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.
Baseline through Week 10
Sleep quality score (0-100)
Tidsramme: 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.
Baseline through Week 10
Daily step count (steps/day)
Tidsramme: 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.
Baseline through Week 10
Activity intensity minutes (minutes/day)
Tidsramme: 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.
Baseline through Week 10
Energy expenditure (kcal/day)
Tidsramme: 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.
Baseline through Week 10
Mean glucose (mmol/L)
Tidsramme: 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.
Baseline through Week 10
Coefficient of variation (%)
Tidsramme: 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.
Baseline through Week 10
Time Below Range (TBR, %)
Tidsramme: 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.
Baseline through Week 10
Time In Range (TIR, %)
Tidsramme: 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.
Baseline through Week 10
Time Above Range (TAR, %)
Tidsramme: 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.
Baseline through Week 10
Postprandial glucose excursion (PPGE) (mmol/L)
Tidsramme: 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.
Baseline through Week 10
Incremental Area Under the Curve (iAUC, mmol/L·min)
Tidsramme: 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.
Baseline through Week 10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National University Health System, Singapore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NUS-IRB-2026-0409

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