- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979978
Healthy Buddies Manitoba
November 1, 2013 updated by: University of Manitoba
Healthy Buddies Manitoba: A Cluster Randomized Controlled Effectiveness Trial of Peer Mentoring for Healthy Eights in Children.
School-based interventions are generally ineffective for preventing weight gain in children.
In 2007, a group from the University of British Columbia, developed a program called Healthy Buddies, that relied on peer mentors to help young children adopt healthy living behaviours.
Pilot studies revealed that the program effectively prevented weight gain in children.
This trial had never been tested on a large scale using a more scientifically sound study design.
We developed a large school-based randomized trial to overcome that limitation and test the hypothesis that that a school-based peer-led healthy living program would reduce adiposity and increase physical activity among children 6-12yrs old.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
647
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Manitoba Institute of Child Health - University of Manitoba
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participating schools need to meet the following eligibility criteria: (1) were within provincial jurisdiction, (2) had a minimum of 200 students per school, (3) offered grades 1 through 6.
Exclusion Criteria:
- Children will be excluded if consent was not received from parents or if they had a condition that limited participation in physical activity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Buddies Curriculum
Healthy buddies curriculum delivered by older peers weekly covering three components of healthy living: Physical activity, healthy eating and a healthy body image.
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Each week, intermediate students will receive a 45-minute healthy-living lesson plan from their classroom teacher.
Later that week, intermediate students will serve as peer mentors ("Buddies"), teaching a 30-minute lesson to their younger students.
The Physical activity (i.e."Go Move!") component of the lesson plans includes 30-minutes of structured aerobic fitness sessions, called fitness loops, with the student pairs twice weekly.
The dietary ("Go Fuel!") component includes lessons about distinguishing nutritious and from unhealthy (nutrient poor-energy rich) foods and beverages.
The body image ("Go Feel Good!") component, the students are taught to value classmates based on individual traits rather than peer influence.
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No Intervention: Control
This group received standard school curriculum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist circumference
Time Frame: 10 months
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Waist circumference at the top of the iliac crest measured in duplicate with a flexible tape.
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10 months
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BMI-Z score
Time Frame: 10 months
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Body mass index Z score is calculated from weight/height2 and normalized to population normative data for age (months) and sex.
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10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 10 months
|
Objectively measured using daily pedometer counts recorded by teachers.
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10 months
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Healthy living knowledge and behaviours
Time Frame: 10 months
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Questionnaires regarding healthy foods and food frequency.
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10 months
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Self efficacy
Time Frame: 10 months
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Questionnaire.
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10 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rob Santos, PhD, Healthy Child Manitoba
- Study Director: Jon McGavock, PhD, Manitoba Institute of Child Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nickel NC, Doupe M, Enns JE, Brownell M, Sarkar J, Chateau D, Burland E, Chartier M, Katz A, Crockett L, Azad MB, McGavock JM, Santos R. Differential effects of a school-based obesity prevention program: A cluster randomized trial. Matern Child Nutr. 2021 Jan;17(1):e13009. doi: 10.1111/mcn.13009. Epub 2020 Aug 20.
- Santos RG, Durksen A, Rabbanni R, Chanoine JP, Lamboo Miln A, Mayer T, McGavock JM. Effectiveness of peer-based healthy living lesson plans on anthropometric measures and physical activity in elementary school students: a cluster randomized trial. JAMA Pediatr. 2014 Apr;168(4):330-7. doi: 10.1001/jamapediatrics.2013.3688. Erratum In: JAMA Pediatr. 2015 Jan;169(1):96.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
November 1, 2013
First Submitted That Met QC Criteria
November 1, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Estimate)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 1, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- H2009:205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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