Healthy Buddies Manitoba

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01979978
First received: November 1, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy Children
Elementary School Age
Rural and Urban
First Nations
Other: Healthy Buddies Curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Buddies Manitoba: A Cluster Randomized Controlled Effectiveness Trial of Peer Mentoring for Healthy Eights in Children.

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Waist circumference [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Waist circumference at the top of the iliac crest measured in duplicate with a flexible tape.

  • BMI-Z score [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Body mass index Z score is calculated from weight/height2 and normalized to population normative data for age (months) and sex.


Secondary Outcome Measures:
  • Physical activity [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Objectively measured using daily pedometer counts recorded by teachers.

  • Healthy living knowledge and behaviours [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Questionnaires regarding healthy foods and food frequency.

  • Self efficacy [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Questionnaire.


Enrollment: 647
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Control
This group received standard school curriculum.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979978

Locations
Canada, Manitoba
Manitoba Institute of Child Health - University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Rob Santos, PhD Healthy Child Manitoba
Study Director: Jon McGavock, PhD Manitoba Institute of Child Health
  More Information

Additional Information:
No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01979978     History of Changes
Other Study ID Numbers: H2009:205
Study First Received: November 1, 2013
Last Updated: November 1, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 18, 2014