NCT01820377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

5.7 years

First QC Date

March 21, 2013

Last Update Submit

September 2, 2016

Conditions

Keywords

Peer-mentoringObesityType 2 DiabetesPhysical ActivityAfter-school program

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Daily Physical Activity

    5 months

  • Rates of overweight/obesity between groups

    5 months

  • Self-Efficacy in Peer Interactions

    5 months

  • Civic Responsibility Survey

    5 months

  • Teacher-on-Pupil Strengths and Difficulties Questionnaire

    5 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Social Determinants of Health

    5 months

Study Arms (2)

Aboriginal Youth Mentorship Program

EXPERIMENTAL

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.

Behavioral: Aboriginal Youth Mentorship Program

Control Group

NO INTERVENTION

This group acts as a control, and are not apart of the Aboriginal Youth Mentorship Program

Interventions

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

Also known as: AYMP
Aboriginal Youth Mentorship Program

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jonathan M McGavock, PhD

    University of Manitoba, Manitoba Institute of Child Health

    PRINCIPAL INVESTIGATOR
  • Joannie Halas, PhD.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 28, 2013

Study Start

October 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations