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
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
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.
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
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)
We'll reach out to this number within 24 hrs