Clinical trial NCT03417128: Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)
Official title: Nutrition and Lifestyle Behaviours in Cardiometabolic Syndrome: Development of a Community-specific Peer-support Programme.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome X
Nutritional and Metabolic Diseases
Health Behavior
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Physically healthy men and women who are ≥ 18 years old.
2. Literate with a fair command of Bahasa Melayu and/or English.
3. Metabolic syndrome status confirmed according to Harmonised Criteria.
4. Willing to attend weekly peer gathering sessions.

Exclusion Criteria:

1. Pregnant, lactating or intend to become pregnant during the study period.
2. Diagnosed with Type 1 Diabetes Mellitus (T1DM)
3. Any predisposing condition compromising the quality of life or ability to participate according to protocol.
4. 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.

Primary outcomes:
measure: Changes from baseline waist circumference at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline systolic blood pressure at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline diastolic blood pressure at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline fasting blood triglyceride levels at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline fasting blood HDL-cholesterol levels at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline fasting blood sugar levels at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Changes from baseline dietary intake at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline physical activity levels at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline health-related quality of life at post-intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up.
timeFrame: Baseline, 3 months, 6 months
measure: Changes from baseline body fat percentage at post intervention and 3 months follow-up
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Intervention Adherence
timeFrame: 3 months
measure: Socio-demographic characteristics
timeFrame: Baseline
measure: Intervention Acceptance
timeFrame: 3 months
Locations:
Study officials:
affiliation: Monash University
name: Amutha Ramadas, PhD
role: PRINCIPAL_INVESTIGATOR
References: