- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02021383
Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students (L2W)
"Lose 2 Win" Contests: A Novel Method to Motivate Weight Loss Maintenance Among College Students
Study Overview
Status
Conditions
Detailed Description
Approximately 30% of college students are overweight or obese. Intervening on excess weight early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance.
"Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. Our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for weight-loss maintenance among college students.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-24 years of age
- University of Minnesota Freshman, Sophomore, or Junior
- Plan on enrolling at the U of Minnesota through Spring 2013
- BMI greater than or equal to 26 and less than or equal to 35.5
- Have working internet and phone access
- Ability to read/write English
- Ability to safely engage in exercise
Exclusion Criteria:
- Currently pregnant or breastfeeding
- Prior or planned weight loss surgery
- Having a special diet or being a member of an "organized weight loss program"
- Diagnosis of Diabetes
- Have had Binge Eating Disorder
- Have lost greater than or equal to 10 pounds in the last 3 months
Study Plan
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 |
|---|---|
|
Experimental: Contest Plus
The Contest Plus group were eligible to receive the financial incentives for weight loss maintenance at three monthly follow ups; weeks 16, 20 and 24.
Eligible participants completed online surveys and in person weigh ins verifying weight maintenance.
In addition to the financial incentives, participants in this group had bi-weekly in person meetings with a Registered Dietician during phase 2 (week 16-24) of the trial.
They also received an in home scale to monitor weight daily.
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Participants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit. Participants in the Contest only and Control group were not eligible to receive these meetings.
Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial.
There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for.
The lottery prize was contingent upon the length of time they maintained their weight loss.
|
|
No Intervention: Control
The Control condition did not receive any intervention and were not eligible to win the lottery based incentive.
Participants completed follow surveys (weeks 16, 20 and 24) and received remuneration for completing surveys and in person weigh in.
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|
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Experimental: Contest Only
The Contest only group were eligible to receive the financial incentives for weight loss maintenance for maintaining weight lost at three monthly follow ups; weeks 16, 20 and 24.
Eligible participants completed online surveys and in person weigh ins verifying weight maintenance.
|
Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial.
There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for.
The lottery prize was contingent upon the length of time they maintained their weight loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10).
Time Frame: Baseline, Week 10, Week 24, Week 52
|
Baseline, Week 10, Week 24, Week 52
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in physical activity from baseline on the Physical Activity Questionnaire at week 24
Time Frame: Baseline, Week 24
|
Baseline, Week 24
|
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Change in physical activity from baseline on the Physical Activity Questionnaire at week 52
Time Frame: Baseline, Week 52
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Baseline, Week 52
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Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24
Time Frame: Baseline, Week 24
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Baseline, Week 24
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Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52
Time Frame: Baseline, Week 52
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Baseline, Week 52
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janet L Thomas, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1207S16661
- 20807 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
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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