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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 September 2016 |
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Main ID: |
NCT01820377 |
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Date of registration:
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21/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Aboriginal Youth Mentorship Program
AYMP |
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Scientific title:
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Northern Lights Physical Activity Program for Management of Type 2 Diabetes Early in Life: Aboriginal Youth Mentorship Program |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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246 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01820377 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jonathan M McGavock, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba, Manitoba Institute of Child Health |
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Name:
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Joannie Halas, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Key inclusion & exclusion criteria
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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.
Age minimum:
8 Years
Age maximum:
11 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Obesity
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Intervention(s)
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Behavioral: Aboriginal Youth Mentorship Program
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Primary Outcome(s)
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Waist Circumference
[Time Frame: 5 months]
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Secondary Outcome(s)
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Teacher-on-Pupil Strengths and Difficulties Questionnaire
[Time Frame: 5 months]
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Rates of overweight/obesity between groups
[Time Frame: 5 months]
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Daily Physical Activity
[Time Frame: 5 months]
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Parent Lifestyle Behaviours Questionnaire
[Time Frame: 5 months]
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Civic Responsibility Survey
[Time Frame: 5 months]
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Self-Efficacy in Peer Interactions
[Time Frame: 5 months]
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Secondary ID(s)
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H2008:060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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