Metabolic Syndrome XPERSUADENCT03417128
Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)
A study testing Peer support in people with Metabolic Syndrome X and Nutritional and Metabolic Diseases, run by Monash University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Nutritional and Metabolic Diseases, Health Behavior
- What is being tested?
- Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Nutrition and Lifestyle Behaviours in Cardiometabolic Syndrome: Development of a Community-specific Peer-support Programme.
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.
Read the 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.
- Being tested
- Peer support
- Medical subject headings
- Metabolic Syndrome, Nutritional and Metabolic Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline waist circumference at post-intervention and 3 months follow-up
Waist circumference will be measured in centimeters using a body tape.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (6)
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.
Measured: Baseline, 3 months, 6 months
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).
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
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).
Measured: Baseline, 3 months, 6 months
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).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start15 Mar 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amutha Ramadas, Monash University
- Investigators
- Amutha Ramadas, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417128
- Sponsor's protocol ID
- CF16/56 - 2016000022
- Acronym
- PERSUADE
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Lifestyle Behaviours in Cardiometabolic Syndrome: Development of a Community-specific Peer-support Programme.
- ClinicalTrials.gov ID
- NCT03417128
- Acronym / sponsor ID
- PERSUADE / CF16/56 - 2016000022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Peer supportThis group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer supportParticipants 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. | Behavioural | Peer support |
Primary outcome
Changes from baseline waist circumference at post-intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
Fasting blood glucose levels will be measured in mmol/l using a glucometer (B.Braun, Germany).
6 secondary outcomes
Changes from baseline dietary intake at post-intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
Changes from baseline physical activity levels at post-intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
Changes from baseline lifestyle behaviour at post-intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
Changes from baseline health-related quality of life at post-intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
Changes from baseline body mass index (BMI) at post intervention and 3 months follow-up.
Time frame: Baseline, 3 months, 6 months
Changes from baseline body fat percentage at post intervention and 3 months follow-up
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amutha Ramadas, PhD principal investigator
Monash University
Questions about this trial
What is this clinical trial studying?
A study testing Peer support in people with Metabolic Syndrome X and Nutritional and Metabolic Diseases, run by Monash University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline waist circumference at post-intervention and 3 months follow-up (time frame: Baseline, 3 months, 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.