Type 2 DiabetesAYMPNCT01820377
The Aboriginal Youth Mentorship Program
A study testing Aboriginal Youth Mentorship Program in people with Type 2 Diabetes and Obesity, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Aboriginal Youth Mentorship Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Aboriginal Youth Mentorship Program
- Keywords
- Peer-mentoring, Obesity, Type 2 Diabetes, Physical Activity, After-school program
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aboriginal Youth Mentorship ProgramBehavioural
Also called AYMP
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (6)
Daily Physical Activity
The secondary outcomes include daily physical activity measured using a pedometer
Measured: 5 months
Rates of overweight/obesity between groups
Rates of overweight and obesity between the groups will be measured before and after the intervention
Measured: 5 months
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.
Measured: 5 months
Civic Responsibility Survey
This scale measures youths' community awareness, knowledge, and investment in helping to improve their community.
Measured: 5 months
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.
Measured: 5 months
Parent Lifestyle Behaviours Questionnaire
Questions about Socioeconomic status, as well as daily physical activity and dietary habits.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startOct 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Institute of Child Health, The Lawson Foundation
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
- Investigators
- Jonathan M McGavock, PhD, Principal investigator, University of Manitoba, Manitoba Institute of Child HealthJoannie Halas, PhD., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820377
- Sponsor's protocol ID
- H2008:060
- Acronym
- AYMP
- Status last verified
- Sep 2016
- First submitted
- 21 Mar 2013
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24819579
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Lights Physical Activity Program for Management of Type 2 Diabetes Early in Life: Aboriginal Youth Mentorship Program
- ClinicalTrials.gov ID
- NCT01820377
- Acronym / sponsor ID
- AYMP / H2008:060
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Peer-mentoring, Obesity, Type 2 Diabetes, Physical Activity, After-school program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Institute of Child Health, The Lawson Foundation
- Study start
- Oct 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aboriginal Youth Mentorship Program | Experimental | Behavioral: Aboriginal Youth Mentorship ProgramHigh 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. |
| Control Group | No intervention | –This group acts as a control, and are not apart of the Aboriginal Youth Mentorship Program |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aboriginal Youth Mentorship ProgramAlso: AYMPHigh 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 | Behavioural | Aboriginal Youth Mentorship Program |
Primary outcome
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.
6 secondary outcomes
Daily Physical Activity
Time frame: 5 months
Rates of overweight/obesity between groups
Time frame: 5 months
Self-Efficacy in Peer Interactions
Time frame: 5 months
Civic Responsibility Survey
Time frame: 5 months
Teacher-on-Pupil Strengths and Difficulties Questionnaire
Time frame: 5 months
Parent Lifestyle Behaviours Questionnaire
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 24819579Eskicioglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M McGavock, PhD principal investigator
University of Manitoba, Manitoba Institute of Child Health
Joannie Halas, PhD. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aboriginal Youth Mentorship Program in people with Type 2 Diabetes and Obesity, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist Circumference (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.