Healthy ChildrenNCT01979978
Healthy Buddies Manitoba
A study testing Healthy Buddies Curriculum in people with Healthy Children and Elementary School Age, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children, Elementary School Age, Rural and Urban
- What is being tested?
- Healthy Buddies Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to May 2013
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children will be excluded if consent was not received from parents or if they had a condition that limited participation in physical activity.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Manitoba Institute of Child Health - University of Manitoba
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: 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.
- Being tested
- Healthy Buddies Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Buddies CurriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Buddies Curriculum | Experimental | Healthy buddies curriculum delivered by older peers weekly covering three components of healthy living: Physical activity, healthy eating and a healthy body image. Receives: Other: Healthy Buddies Curriculum |
| Control | No intervention | This group received standard school curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Waist circumference at the top of the iliac crest measured in duplicate with a flexible tape.
Measured: 10 months
BMI-Z score
Body mass index Z score is calculated from weight/height2 and normalized to population normative data for age (months) and sex.
Measured: 10 months
Secondary outcomes (3)
Physical activity
Objectively measured using daily pedometer counts recorded by teachers.
Measured: 10 months
Healthy living knowledge and behaviours
Questionnaires regarding healthy foods and food frequency.
Measured: 10 months
Self efficacy
Questionnaire.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Santos, PhD, Principal investigator, Healthy Child ManitobaJon McGavock, PhD, Study director, Manitoba Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979978
- Sponsor's protocol ID
- H2009:205
- Status last verified
- Oct 2013
- First submitted
- 1 Nov 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32815644Santos 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.
PubMed 24515353
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Buddies Manitoba: A Cluster Randomized Controlled Effectiveness Trial of Peer Mentoring for Healthy Eights in Children.
- ClinicalTrials.gov ID
- NCT01979978
- Acronym / sponsor ID
- H2009:205
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Buddies Curriculum | Experimental | Other: Healthy Buddies CurriculumHealthy buddies curriculum delivered by older peers weekly covering three components of healthy living: Physical activity, healthy eating and a healthy body image. |
| Control | No intervention | –This group received standard school curriculum. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children will be excluded if consent was not received from parents or if they had a condition that limited participation in physical 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 |
|---|---|---|
| Healthy Buddies CurriculumEach 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. | Other | Healthy Buddies Curriculum |
Primary outcome
Waist circumference
Time frame: 10 months
Waist circumference at the top of the iliac crest measured in duplicate with a flexible tape.
BMI-Z score
Time frame: 10 months
Body mass index Z score is calculated from weight/height2 and normalized to population normative data for age (months) and sex.
3 secondary outcomes
Physical activity
Time frame: 10 months
Healthy living knowledge and behaviours
Time frame: 10 months
Self efficacy
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 32815644Nickel 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.
- Derived from this study: PubMed 24515353Santos 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.
- Intervention WebsiteLink provided by the sponsor.
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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.
Rob Santos, PhD principal investigator
Healthy Child Manitoba
Jon McGavock, PhD study director
Manitoba Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Buddies Curriculum in people with Healthy Children and Elementary School Age, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Waist circumference (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979978, which also lists 2 linked publications.
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 8 Nov 2013.