Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)

Study Overview
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Brief Summary
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The outlook of a community-based intervention targeting nutrition and lifestyle behaviour modification among adults with metabolic syndrome (MetS) has not been fully explored. The primary aim of this study (PERSUADE) is to evaluate the effect of the peer support intervention on the clinical outcomes MetS components followed by improvements in the participants' dietary practices, physical activity levels and lifestyle behaviours. The program constructed using information obtained from the published clinical and dietary guideline in Malaysia.

Detailed Description
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Aim: To develop and assess a three-month, group-based community peer support program for Malaysian adults with MetS. Method: The PERSUADE module will be constructed using the Health Belief Model (HBM) to address relevant health messages from the appropriate guidelines and recent literature evidence on MetS among Malaysian adults. Following that, a minimum sample of 96 Malaysian adults with MetS will be randomised, either to the control group, who will receive one-time standard nutrition and lifestyle advice or the intervention group, who will participate in a three-month peer support program using the PERSUADE module. The participants will be followed up for three months post-intervention with data collection scheduled at baseline, 3-month and 6-month. PERSUADE is thoroughly designed using the current available guidelines informed with gathered inputs on motivations and barriers towards healthy lifestyle among Malaysians. The program aims to improve the clinical outcomes of MetS component among participants of the intervention group, besides the impact of the peer support intervention on the dietary practices, physical activity levels and lifestyle behaviours of those participants. The successful outcome of this study can be an initiator for policy makers to encourage more rigorous promotion of such community-based programmes in the country.

Official Title
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Nutrition and Lifestyle Behaviours in Cardiometabolic Syndrome: Development of a Community-specific Peer-support Programme.

Conditions
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Metabolic Syndrome X, Nutritional and Metabolic Diseases, Health Behavior

Intervention / Treatment
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* Behavioral: Peer support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physically healthy men and women who are ≥ 18 years old. Literate with a fair command of Bahasa Melayu and/or English. Metabolic syndrome status confirmed according to Harmonised Criteria. Willing to attend weekly peer gathering sessions. Exclusion Criteria: Pregnant, lactating or intend to become pregnant during the study period. Diagnosed with Type 1 Diabetes Mellitus (T1DM) Any predisposing condition compromising the quality of life or ability to participate according to protocol. Reported severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the participants' ability to follow the participation in peer activity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in the control group will receive a one-time personalised nutrition and lifestyle advised based from the Malaysian Dietary Guideline 2010. They will be assured to be followed up twice for the next six month. | |
| Experimental: Peer support<br>This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering. | Behavioral: Peer support<br>* Participants residing in the location selected to be intervene will to form at minimum 4 peer groups. This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering. Two participants from each peer group will be selected as the peer leader (PL). PL will be trained to deliver the content of PERSUADE modules and will be responsible to run a weekly peer gathering with their respective groups for the following three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline waist circumference at post-intervention and 3 months follow-up | Waist circumference will be measured in centimeters using a body tape. | Baseline, 3 months, 6 months | 
| Changes from baseline systolic blood pressure at post-intervention and 3 months follow-up | Systolicblood pressure will be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan). | Baseline, 3 months, 6 months | 
| Changes from baseline diastolic blood pressure at post-intervention and 3 months follow-up | Diastolic blood pressure be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan). | Baseline, 3 months, 6 months | 
| Changes from baseline fasting blood triglyceride levels at post-intervention and 3 months follow-up | Fasting blood triglyceride levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA). | Baseline, 3 months, 6 months | 
| Changes from baseline fasting blood HDL-cholesterol levels at post-intervention and 3 months follow-up | Fasting blood HDL-cholesterol levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA). | Baseline, 3 months, 6 months | 
| Changes from baseline fasting blood sugar levels at post-intervention and 3 months follow-up | Fasting blood glucose levels will be measured in mmol/l using a glucometer (B.Braun, Germany). | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline dietary intake at post-intervention and 3 months follow-up | A 3-days 24 hour dietary recall will be done and analysed using a software (Nutritionist Pro, Axxya System, USA). Total calories intake (kcal) and macronutrients profile; carbohydrate, fat and protein (grams and percentage of daily energy intake) will be sought. | Baseline, 3 months, 6 months | 
| Changes from baseline physical activity levels at post-intervention and 3 months follow-up | Physical activity levels will be measured using a validated short form International Physical Activity Questionnaire (IPAQ) and will be expressed in metabolic equivalent quotient (METS). | Baseline, 3 months, 6 months | 
| Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up | A short questionnaire will be developed to gather information of sleep duration, smoking and alcohol consumption. | Baseline, 3 months, 6 months | 
| Changes from baseline health-related quality of life at post-intervention and 3 months follow-up | Health-related quality of life will be measured using validated WHO-BREF Quality of life questionnaire. | Baseline, 3 months, 6 months | 
| Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up. | Body weight (kilograms) and height (meters) will be combined and expressed as BMI (kg/m^2). | Baseline, 3 months, 6 months | 
| Changes from baseline body fat percentage at post intervention and 3 months follow-up | Body fat percentage will be estimated using a body composition analyser (In-Body, Korea). | Baseline, 3 months, 6 months |