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

Monash University

Status: Unknown

Conditions: Health Behavior; Metabolic Syndrome X; Nutritional and Metabolic Diseases

Treatments: Behavioral: Peer support

Study type: Interventional

Funder types: Other

Identifiers

NCT03417128

CF16/56 - 2016000022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Peer support

Experimental group

Description:

This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering.

Treatment:

Behavioral: Peer support