Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)
- Conditions
- Metabolic Syndrome XHealth BehaviorNutritional and Metabolic Diseases
- Interventions
- Behavioral: Peer support
- Registration Number
- NCT03417128
- Lead Sponsor
- Monash University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peer support Peer support This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering.
- Primary Outcome Measures
Name Time Method Changes from baseline systolic blood pressure at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Systolicblood pressure will be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan).
Changes from baseline fasting blood HDL-cholesterol levels at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Fasting blood HDL-cholesterol levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA).
Changes from baseline diastolic blood pressure at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Diastolic blood pressure be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan).
Changes from baseline waist circumference at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Waist circumference will be measured in centimeters using a body tape.
Changes from baseline fasting blood triglyceride levels at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Fasting blood triglyceride levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA).
Changes from baseline fasting blood sugar levels at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Fasting blood glucose levels will be measured in mmol/l using a glucometer (B.Braun, Germany).
- Secondary Outcome Measures
Name Time Method Changes from baseline physical activity levels at post-intervention and 3 months follow-up Baseline, 3 months, 6 months 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).
Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up. Baseline, 3 months, 6 months Body weight (kilograms) and height (meters) will be combined and expressed as BMI (kg/m\^2).
Changes from baseline health-related quality of life at post-intervention and 3 months follow-up Baseline, 3 months, 6 months Health-related quality of life will be measured using validated WHO-BREF Quality of life questionnaire.
Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up Baseline, 3 months, 6 months A short questionnaire will be developed to gather information of sleep duration, smoking and alcohol consumption.
Changes from baseline body fat percentage at post intervention and 3 months follow-up Baseline, 3 months, 6 months Body fat percentage will be estimated using a body composition analyser (In-Body, Korea).
Changes from baseline dietary intake at post-intervention and 3 months follow-up Baseline, 3 months, 6 months 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.