Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Time-restricted eating (Behavioral)
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.
干预措施: Physical Activity (Behavioral)
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.
干预措施: Low Glycemic Load diet (Behavioral)
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.
干预措施: Sleep hygiene (Behavioral)
结局指标
主要结局
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: 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).
次要结局
- Glycated haemoglobin (HbA1c) (%)(At baseline, Week 10)
- Fasting plasma glucose (mmol/L)(At baseline, Week 10)
- Fasting Insulin (µIU/mL)(At baseline, Week 10)
- Total cholesterol (mmol/L)(At baseline, Week 10)
- High-density lipoprotein cholesterol (HDL-C) (mmol/L)(At baseline, Week 10)
- Low-density lipoprotein cholesterol (LDL-C) (mmol/L)(At baseline, Week 10)
- Cholesterol/HDL ratio(At baseline, Week 10)
- Triglycerides (mmol/L)(At baseline, Week 10)
- Lipoprotein a (nmol/L)(At baseline, Week 10)
- Apolipoprotein A1 (g/L)(At baseline, Week 10)
- Apolipoprotein B (g/L)(At baseline, Week 10)
- Apolipoprotein B/ A1 ratio(At baseline, Week 10)
- High-sensitivity C-reactive protein (hs-CRP) (mg/L)(At baseline, Week 10)
- Total protein (g/L)(At baseline, Week 10)
- Albumin (g/L)(At baseline, Week 10)
- Globulin (g/L)(At baseline, Week 10)
- A/G ratio(At baseline, Week 10)
- Bilirubin (µmol/L)(At baseline, Week 10)
- Alkaline phosphatase (ALP) (U/L)(At baseline, Week 10)
- Alanine aminotransferase (ALT/SGPT) (U/L)(At baseline, Week 10)
- Aspartate aminotransferase (AST/SGOT) (U/L)(At baseline, Week 10)
- Blood pressure (mmHg)(At baseline, Week 10)
- Montreal Cognitive Assessment (MoCA)(At baseline, Week 10)
- Hand grip strength (kg)(At baseline, Week 10)
- Weight (kg)(At baseline, Weeks 5,10)
- Waist circumference (cm)(At baseline, Weeks 5,10)
- Body mass index (BMI) (kg/m²)(At baseline, Weeks 5,10)
- Percentage Body Fat (%)(At baseline, Weeks 5,10)
- Body Fat Mass (kg)(At baseline, Weeks 5,10)
- Visceral Fat Level(At baseline, Week 10)
- ABSI (body shape index)(At baseline, Weeks 5,10)
- BRI (body roundness index)(At baseline, Weeks 5,10)
- Three Factor Eating Questionnaire (TFEQ)(At baseline, Week 10)
- International Physical Activity Questionnaire Short-Form (IPAQ-SF)(At baseline, Week 10)
- Generalized Anxiety Disorder 7-item (GAD-7)(At baseline, Week 10)
- Patient Health Questionnaire-9 (PHQ-9)(At baseline, Week 10)
- Perceived Stress Scale (PSS-10)(At baseline, Week 10)
- Heart rate recovery (beats/min)(Baseline through Week 10)
- Big Five Inventory - 44 item (BFI-44)(At baseline, Week 10)
- Sleep Hygiene Index (SHI)(At baseline, Week 10)
- Gut microbiome(At baseline, Week 10)
- Resting heart rate (beats/min)(Baseline through Week 10)
- Heart rate variability (ms)(Baseline through Week 10)
- Sleep duration (hours)(Baseline through Week 10)
- Sleep quality score (0-100)(Baseline through Week 10)
- Daily step count (steps/day)(Baseline through Week 10)
- Activity intensity minutes (minutes/day)(Baseline through Week 10)
- Energy expenditure (kcal/day)(Baseline through Week 10)
- Mean glucose (mmol/L)(Baseline through Week 10)
- Coefficient of variation (%)(Baseline through Week 10)
- Time Below Range (TBR, %)(Baseline through Week 10)
- Time In Range (TIR, %)(Baseline through Week 10)
- Time Above Range (TAR, %)(Baseline through Week 10)
- Postprandial glucose excursion (PPGE) (mmol/L)(Baseline through Week 10)
- Incremental Area Under the Curve (iAUC, mmol/L·min)(Baseline through Week 10)
研究者
Jocelyn Chew
Assistant Professor
National University Health System, Singapore