- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820377
The Aboriginal Youth Mentorship Program (AYMP)
September 2, 2016 updated by: Jon McGavock, University of Manitoba
Northern Lights Physical Activity Program for Management of Type 2 Diabetes Early in Life: Aboriginal Youth Mentorship Program
Building on the successes of a communal, relationship based approach to Aboriginal youth mentoring in an after school physical activity program (AYMP), the investigators are evaluating a peer-led approach for diabetes prevention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Building on the successes of a communal, relationship based approach to Aboriginal youth mentoring in an after school physical activity program (AYMP), the investigators are evaluating a peer-led approach for diabetes prevention.
High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week.
The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity.
The second day, they deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities.
Our primary goal is to determine the health benefits of AYMP; guided by our youth mentors and community advisors, the investigators will also develop a number of research questions that will help us to better understand the social, emotional, physical and spiritual outcomes of the peer-led mentor program.
To answer these questions, the investigators will train community members in both qualitative and quantitative methods.
The quantitative outcomes of this study include physical activity, waist circumference, obesity rates, and self-esteem.
Qualitative methods may include photovoice and focus group interviews.
All of these will be used to assess the social determinants of health and contextual features of the program.
Study Type
Interventional
Enrollment (Actual)
246
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
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 3P4
- Children's Hospital Research Institute of Manitoba
-
-
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
8 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Grade 4 students. We chose to intervene with youth in grade 4 for four primary reasons: (1) the large majority of youth in grade 4 are in tanner stage 1 and will not experience puberty-related weight gain during the school year; (2) previous experience by our group revealed that attendance throughout the school year is higher in students in grade 4 relative to students in grade 5 or 6; (3) students in grade 4 are old enough to perform low organized games included in the intervention; and (4) retention rates in the intervention are greater than students in grades 5 and 6.
Exclusion Criteria:
- While all students will be invited to participate in the intervention, for measurement purposes, we will exclude data from those students who may not respond to the intervention or would be unable to participate in the physical activity aspects of the component. This includes children with: (1) musculoskeletal injuries that limit physical activities; (2) treatment for chronic conditions that would elicit weight gain or limit participation in physical activity (insulin, corticosteroids, blood pressure medications); (3) poor attendance (<60% of school days) in the first semester; (4) children whose parents are unwilling to provide consent. Note: the intervention will be offered to youth with chronic conditions, however their data will not be included in the final analysis, due to confounding effects of medications.
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: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aboriginal Youth Mentorship Program
High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week.
The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity.
The second day, they deliver the program to the grade 4 students, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities.
Grade 4s act as the intervention group.
|
High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week.
The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity.
The second day, they deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities.
Grade 4s are our intervention group
Other Names:
|
No Intervention: Control Group
This group acts as a control, and are not apart of the Aboriginal Youth Mentorship Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist Circumference
Time Frame: 5 months
|
The primary outcome will be waist circumference measured at the level of the iliac crest.
Waist circumference is a clinically relevant outcome as it is a robust predictor of Type 2 Diabetes in youth and other cardiometabolic outcomes in youth.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Physical Activity
Time Frame: 5 months
|
The secondary outcomes include daily physical activity measured using a pedometer
|
5 months
|
Rates of overweight/obesity between groups
Time Frame: 5 months
|
Rates of overweight and obesity between the groups will be measured before and after the intervention
|
5 months
|
Self-Efficacy in Peer Interactions
Time Frame: 5 months
|
This scale is designed to measure youths' perceptions of their ability to be successful in social interactions.
This includes their ability to be persuasive towards peers in positive ways.
The questionnaire contains two subscales that measure social self-efficacy in conflict and non-conflict situations.
The subscales can be used separately or combined into a total score.
|
5 months
|
Civic Responsibility Survey
Time Frame: 5 months
|
This scale measures youths' community awareness, knowledge, and investment in helping to improve their community.
|
5 months
|
Teacher-on-Pupil Strengths and Difficulties Questionnaire
Time Frame: 5 months
|
The Teacher on Pupil Questionnaire for the Child Cohort recorded specific information about the Study child, such as temperament, academic performance and school preparedness.
|
5 months
|
Parent Lifestyle Behaviours Questionnaire
Time Frame: 5 months
|
Questions about Socioeconomic status, as well as daily physical activity and dietary habits.
|
5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Determinants of Health
Time Frame: 5 months
|
The investigators recognize that the structural social determinants of health including income inequality, local wealth, sex and ethnic inequalities are key aspects to adolescent health in Aboriginal adolescents.
The investigators also recognize that these are unlikely to change with the AYMP.
Therefore the investigators will focus on a series of proximal factors.
Using Indigenous approaches (i.e.
sharing circles, storytelling) the investigators will explore the influence of the AYMP on (1) respect (a major theme in pilot testing), (2) perceived changes in the school environment, (3) family connectedness, (4) peer influence and (5) health behaviours.
If youth prefer to discuss issues in a private setting, opportunities will be provided.
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan M McGavock, PhD, University of Manitoba, Manitoba Institute of Child Health
- Principal Investigator: Joannie Halas, PhD., University of Manitoba
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.
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
October 1, 2010
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 21, 2013
First Submitted That Met QC Criteria
March 25, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Estimate)
September 5, 2016
Last Update Submitted That Met QC Criteria
September 2, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2008:060
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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