- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00722345
Exercise Consultation in Obese Youth
July 24, 2008 updated by: St. Justine's Hospital
Can Exercise Consultation Increase Activity Levels and Improve Metabolic Markers in Obese Adolescents? A Pilot Study.
Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults.
It is unknown whether this approach would be efficacious with youth.
The purpose of this pilot study was to assess whether exercise consultation would increase PA levels and improve anthropometric measures and metabolic markers in obese adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Centre hospitalier universitaire Ste-Justine
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-
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
Ages Eligible for Study
14 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescents
- BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)
Exclusion Criteria:
- Pregnancy
- Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 2
|
The exercise consultation consisted of a one-to-one discussion designed to educate the participant, strengthen his/her motivation and develop realistic goals and strategies to promote physical activity based on the patient's stage of change.
The consultation was based upon the standardized protocol previously published by Loughlan and Mutrie.
The Consultation Guidelines describe the 5 steps involved in an exercise consultation, including: 1) discussing current & past activities; 2) reviewing the pros & cons of exercising; 3) discussing the barriers to exercising and strategies for overcoming them; 4) determining the social support available to the patient; and finally, 5) setting realistic, attainable short term and long term goals to enhance physical activity.
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PLACEBO_COMPARATOR: 1
|
The contents of the exercise booklet was reviewed with each participant of the control group by the research fellow.
Health Canada's "Canada's Physical Activity Guide for Youth" was used for the exercise booklet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical activity counts per minute (accelerometer data)
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stage of change
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
|
Lipids
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
|
Glucose
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
|
Insulin
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
|
Blood pressure
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
|
Anthropometric mesures (height, weight, waist circumference, hip circumference)
Time Frame: At baseline and at 3 months
|
At baseline and at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melanie Henderson, MD MSc FRCP, Ste-Justine Hospital/McGill University
- Principal Investigator: Celine Huot, MD MSc, Ste-Justine Hospital/University of Montreal
- Principal Investigator: Denis Daneman, MB BCh FRCP, University of Toronto
- Principal Investigator: Janet Hux, MD SM, University of Toronto
- Principal Investigator: Anthony Hanley, PhD, University of Toronto
- Principal Investigator: Jennifer McGrath, PhD MPH, Concordia University, Montreal
- Principal Investigator: Marie Lambert, MD, Ste-Justine Hospital/University of Montreal
- Principal Investigator: Gillian L Booth, MD MSc, University of Toronto
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
June 1, 2005
Primary Completion (ACTUAL)
August 1, 2006
Study Completion (ACTUAL)
August 1, 2006
Study Registration Dates
First Submitted
July 23, 2008
First Submitted That Met QC Criteria
July 24, 2008
First Posted (ESTIMATE)
July 25, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 25, 2008
Last Update Submitted That Met QC Criteria
July 24, 2008
Last Verified
June 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2162
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.