The Aboriginal Youth Mentorship Program

Obesity Clinical Trial

— AYMP  

Official title:

Northern Lights Physical Activity Program for Management of Type 2 Diabetes Early in Life: Aboriginal Youth Mentorship Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820377
• Other study ID #: H2008:060
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: September 2, 2016
• Start date: October 2010
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• 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 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities. Grade 4s are our intervention group

Locations

Country	Name	City	State
Canada	Children's Hospital Research Institute of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Institute of Child Health, The Lawson Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Determinants of Health	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	No
Primary	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.	5 months	No
Secondary	Daily Physical Activity	The secondary outcomes include daily physical activity measured using a pedometer	5 months	No
Secondary	Rates of overweight/obesity between groups	Rates of overweight and obesity between the groups will be measured before and after the intervention	5 months	No
Secondary	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.	5 months	No
Secondary	Civic Responsibility Survey	This scale measures youths' community awareness, knowledge, and investment in helping to improve their community.	5 months	No
Secondary	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.	5 months	No
Secondary	Parent Lifestyle Behaviours Questionnaire	Questions about Socioeconomic status, as well as daily physical activity and dietary habits.	5 months	No