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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other Names:
  • AYMP
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Lawson Foundation
Manitoba Institute of Child Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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