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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNational University Health System, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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;

Disqualifiers

(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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: PRISMExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

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).

Time frame
At baseline, Week 10

Secondary outcomes

1

Glycated haemoglobin (HbA1c) (%)

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.

Time frame
At baseline, Week 10
2

Fasting plasma glucose (mmol/L)

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.

Time frame
At baseline, Week 10
3

Fasting Insulin (µIU/mL)

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.

Time frame
At baseline, Week 10
4

Total cholesterol (mmol/L)

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.

Time frame
At baseline, Week 10

Other outcomes

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