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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01979978
Other study ID # H2009:205
Secondary ID
Status Completed
Phase N/A
First received November 1, 2013
Last updated November 1, 2013
Start date September 2009
Est. completion date May 2013

Study information

Verified date October 2013
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 647
Est. completion date May 2013
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Intervention

Other:
Healthy Buddies Curriculum
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.

Locations

Country Name City State
Canada Manitoba Institute of Child Health - University of Manitoba Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waist circumference Waist circumference at the top of the iliac crest measured in duplicate with a flexible tape. 10 months
Primary BMI-Z score Body mass index Z score is calculated from weight/height2 and normalized to population normative data for age (months) and sex. 10 months
Secondary Physical activity Objectively measured using daily pedometer counts recorded by teachers. 10 months
Secondary Healthy living knowledge and behaviours Questionnaires regarding healthy foods and food frequency. 10 months
Secondary Self efficacy Questionnaire. 10 months
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