Prevention of Weight Gain in University Students (PGP2)
Primary Purpose
Prevention, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle intervention seminars
Sponsored by
About this trial
This is an interventional prevention trial for Prevention
Eligibility Criteria
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.
Sites / Locations
- Université de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Small-group seminar for 2 years
Small-group seminars for 1 year followed by email intervention
Arm Description
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
Full Information
NCT ID
NCT00995462
First Posted
October 14, 2009
Last Updated
December 10, 2013
Sponsor
Marie-France Hivert
Collaborators
Canadian Diabetes Association, Danone Institute
1. Study Identification
Unique Protocol Identification Number
NCT00995462
Brief Title
Prevention of Weight Gain in University Students
Acronym
PGP2
Official Title
Prevention of Weight Gain in University Students
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marie-France Hivert
Collaborators
Canadian Diabetes Association, Danone Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention, Weight Gain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Small-group seminar for 2 years
Arm Type
Experimental
Arm Title
Small-group seminars for 1 year followed by email intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention seminars
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1K 2R1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21536060
Citation
Langlois F, Langlois MF, Carpentier AC, Brown C, Lemieux S, Hivert MF. Ghrelin levels are associated with hunger as measured by the Three-Factor Eating Questionnaire in healthy young adults. Physiol Behav. 2011 Sep 1;104(3):373-7. doi: 10.1016/j.physbeh.2011.04.013. Epub 2011 Apr 22.
Results Reference
derived
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Prevention of Weight Gain in University Students
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