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

NCT03417128 | Unknown

• 1 other identifier: CF16/56 - 2016000022
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome X; Nutritional and Metabolic Diseases; Health Behavior

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Changes from baseline dietary intake at post-intervention and 3 months follow-up

  Baseline, 3 months, 6 months

• Changes from baseline physical activity levels at post-intervention and 3 months follow-up

  Baseline, 3 months, 6 months

• Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up

  Baseline, 3 months, 6 months

• Changes from baseline health-related quality of life at post-intervention and 3 months follow-up

  Baseline, 3 months, 6 months

• Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up.

  Baseline, 3 months, 6 months

Other Outcomes (3)

• Intervention Adherence

  3 months

• Socio-demographic characteristics

  Baseline

• Intervention Acceptance

  3 months

Study Arms (2)

Control

NO INTERVENTION

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

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

Behavioral: Peer support

Interventions

Peer support BEHAVIORAL

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.

Peer support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead

MeSH Terms

Conditions

Metabolic Syndrome; Nutritional and Metabolic Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Amutha Ramadas, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 31, 2018
• Study Start: March 15, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2021
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share