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

Primary Purpose

Metabolic Syndrome X, Nutritional and Metabolic Diseases, Health Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer support
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Peer support

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Changes from baseline waist circumference at post-intervention and 3 months follow-up
    Waist circumference will be measured in centimeters using a body tape.
    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    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.
    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).
    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.
    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.
    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).
    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).

    Full Information

    First Posted
    December 26, 2017
    Last Updated
    January 24, 2018
    Sponsor
    Monash University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03417128
    Brief Title
    Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)
    Acronym
    PERSUADE
    Official Title
    Nutrition and Lifestyle Behaviours in Cardiometabolic Syndrome: Development of a Community-specific Peer-support Programme.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2016 (Actual)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Monash University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome X, Nutritional and Metabolic Diseases, Health Behavior

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Peer support
    Arm Type
    Experimental
    Arm Description
    This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer support
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes from baseline waist circumference at post-intervention and 3 months follow-up
    Description
    Waist circumference will be measured in centimeters using a body tape.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline systolic blood pressure at post-intervention and 3 months follow-up
    Description
    Systolicblood pressure will be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline diastolic blood pressure at post-intervention and 3 months follow-up
    Description
    Diastolic blood pressure be expressed in mmHg using an automated blood pressure monitor (OMRON, Japan).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline fasting blood triglyceride levels at post-intervention and 3 months follow-up
    Description
    Fasting blood triglyceride levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline fasting blood HDL-cholesterol levels at post-intervention and 3 months follow-up
    Description
    Fasting blood HDL-cholesterol levels will be measured in mmol/l using a blood lipid meter (Cardiocheck PA, USA).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline fasting blood sugar levels at post-intervention and 3 months follow-up
    Description
    Fasting blood glucose levels will be measured in mmol/l using a glucometer (B.Braun, Germany).
    Time Frame
    Baseline, 3 months, 6 months
    Secondary Outcome Measure Information:
    Title
    Changes from baseline dietary intake at post-intervention and 3 months follow-up
    Description
    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.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline physical activity levels at post-intervention and 3 months follow-up
    Description
    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).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up
    Description
    A short questionnaire will be developed to gather information of sleep duration, smoking and alcohol consumption.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline health-related quality of life at post-intervention and 3 months follow-up
    Description
    Health-related quality of life will be measured using validated WHO-BREF Quality of life questionnaire.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up.
    Description
    Body weight (kilograms) and height (meters) will be combined and expressed as BMI (kg/m^2).
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Changes from baseline body fat percentage at post intervention and 3 months follow-up
    Description
    Body fat percentage will be estimated using a body composition analyser (In-Body, Korea).
    Time Frame
    Baseline, 3 months, 6 months
    Other Pre-specified Outcome Measures:
    Title
    Intervention Adherence
    Description
    Measure of Intervention adherence will based on participant attendance which is done by collecting given peer support posters, at the post-intervention level.
    Time Frame
    3 months
    Title
    Socio-demographic characteristics
    Description
    A brief questionnaire will be administered at the baseline to gather information on sociodemographic characteristic of participants including their age, gender, ethnicity and income levels.
    Time Frame
    Baseline
    Title
    Intervention Acceptance
    Description
    Measure of acceptance will be measured using a short questionnaire which contains a series of three point scales scoring at the post-intervention level.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amutha Ramadas, PhD
    Organizational Affiliation
    Monash University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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