Back to resultsThe Aboriginal Youth Mentorship Program (AYMP)
Primary Purpose
Type 2 Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aboriginal Youth Mentorship Program
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Peer-mentoring, Obesity, Type 2 Diabetes, Physical Activity, After-school program
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital Research Institute of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aboriginal Youth Mentorship Program
Control Group
Arm Description
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.
This group acts as a control, and are not apart of the Aboriginal Youth Mentorship Program
Outcomes
Primary Outcome Measures
Waist Circumference
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.
Secondary Outcome Measures
Daily Physical Activity
The secondary outcomes include daily physical activity measured using a pedometer
Rates of overweight/obesity between groups
Rates of overweight and obesity between the groups will be measured before and after the intervention
Self-Efficacy in Peer Interactions
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.
Civic Responsibility Survey
This scale measures youths' community awareness, knowledge, and investment in helping to improve their community.
Teacher-on-Pupil Strengths and Difficulties Questionnaire
The Teacher on Pupil Questionnaire for the Child Cohort recorded specific information about the Study child, such as temperament, academic performance and school preparedness.
Parent Lifestyle Behaviours Questionnaire
Questions about Socioeconomic status, as well as daily physical activity and dietary habits.
Full Information
NCT ID
NCT01820377
First Posted
March 21, 2013
Last Updated
September 2, 2016
Sponsor
University of Manitoba
Collaborators
Manitoba Institute of Child Health, The Lawson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01820377
Brief Title
The Aboriginal Youth Mentorship Program
Acronym
AYMP
Official Title
Northern Lights Physical Activity Program for Management of Type 2 Diabetes Early in Life: Aboriginal Youth Mentorship Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Institute of Child Health, The Lawson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
Keywords
Peer-mentoring, Obesity, Type 2 Diabetes, Physical Activity, After-school program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aboriginal Youth Mentorship Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group acts as a control, and are not apart of the Aboriginal Youth Mentorship Program
Intervention Type
Behavioral
Intervention Name(s)
Aboriginal Youth Mentorship Program
Other Intervention Name(s)
AYMP
Intervention Description
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
Primary Outcome Measure Information:
Title
Waist Circumference
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Daily Physical Activity
Description
The secondary outcomes include daily physical activity measured using a pedometer
Time Frame
5 months
Title
Rates of overweight/obesity between groups
Description
Rates of overweight and obesity between the groups will be measured before and after the intervention
Time Frame
5 months
Title
Self-Efficacy in Peer Interactions
Description
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.
Time Frame
5 months
Title
Civic Responsibility Survey
Description
This scale measures youths' community awareness, knowledge, and investment in helping to improve their community.
Time Frame
5 months
Title
Teacher-on-Pupil Strengths and Difficulties Questionnaire
Description
The Teacher on Pupil Questionnaire for the Child Cohort recorded specific information about the Study child, such as temperament, academic performance and school preparedness.
Time Frame
5 months
Title
Parent Lifestyle Behaviours Questionnaire
Description
Questions about Socioeconomic status, as well as daily physical activity and dietary habits.
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Social Determinants of Health
Description
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.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M McGavock, PhD
Organizational Affiliation
University of Manitoba, Manitoba Institute of Child Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joannie Halas, PhD.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Research Institute of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24819579
Citation
Eskicioglu P, Halas J, Senechal M, Wood L, McKay E, Villeneuve S, Shen GX, Dean H, McGavock JM. Peer mentoring for type 2 diabetes prevention in first nations children. Pediatrics. 2014 Jun;133(6):e1624-31. doi: 10.1542/peds.2013-2621. Epub 2014 May 12.
Results Reference
derived
Learn more about this trial
The Aboriginal Youth Mentorship Program
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