- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00995462
Prevention of Weight Gain in University Students (PGP2)
December 10, 2013 updated by: Marie-France Hivert
This study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
319
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
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1K 2R1
- Universite de Sherbrooke
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First year students at the Université de Sherbrooke.
Exclusion Criteria:
- Presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.).
- Pregnancy or planning a pregnancy in the next two years.
- Unable to give an informed consent.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Small-group seminar for 2 years
|
The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts.
A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.
|
Experimental: Small-group seminars for 1 year followed by email intervention
|
The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts.
A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight change
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-France Langlois, MD, Universite de Sherbrooke
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.
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
September 1, 2006
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 14, 2009
First Submitted That Met QC Criteria
October 14, 2009
First Posted (Estimate)
October 15, 2009
Study Record Updates
Last Update Posted (Estimate)
December 11, 2013
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-025
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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