An interventional study of Peer support in Metabolic Syndrome X, Nutritional and Metabolic Diseases and Health Behavior, sponsored by Monash University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Monash University · Not applicable, Interventional, and Prevention
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.
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.
2,117 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 1,573 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Peer support
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.
Changes from baseline waist circumference at post-intervention and 3 months follow-up
Waist circumference will be measured in centimeters using a body tape.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 3 months, 6 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 3 months, 6 months
Intervention Adherence
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
Socio-demographic characteristics
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
Intervention Acceptance
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
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2016 (actual). Primary completion is estimated for Mar 2019, 36 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 36 months is above that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Monash University