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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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).
• Поведенческое 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
• Поведенческое 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
• Поведенческое 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).

Первичные конечные точки

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Срок оценки: At baseline, Week 10]

Вторичные конечные точки (12)

• Glycated haemoglobin (HbA1c) (%) [Срок оценки: At baseline, Week 10]
• Fasting plasma glucose (mmol/L) [Срок оценки: At baseline, Week 10]
• Fasting Insulin (µIU/mL) [Срок оценки: At baseline, Week 10]
• Total cholesterol (mmol/L) [Срок оценки: At baseline, Week 10]
• High-density lipoprotein cholesterol (HDL-C) (mmol/L) [Срок оценки: At baseline, Week 10]
• Low-density lipoprotein cholesterol (LDL-C) (mmol/L) [Срок оценки: At baseline, Week 10]
• Cholesterol/HDL ratio [Срок оценки: At baseline, Week 10]
• Triglycerides (mmol/L) [Срок оценки: At baseline, Week 10]
• Lipoprotein a (nmol/L) [Срок оценки: At baseline, Week 10]
• Apolipoprotein A1 (g/L) [Срок оценки: At baseline, Week 10]
• Apolipoprotein B (g/L) [Срок оценки: At baseline, Week 10]
• Apolipoprotein B/ A1 ratio [Срок оценки: At baseline, Week 10]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National University of Singapore — Singapore

Идентификаторы

NCT: NCT07710274 · NUS-IRB-2026-0409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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