- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053260
Contingency Management for Promoting Weight Loss in University Students (WeLCoMe)
April 5, 2019 updated by: UConn Health
Rates of overweight and obesity are increasing, particularly among individuals aged 18 to 29.
An estimated 25-35% of American college and university students are overweight or obese.
Contingency Management (CM) is a behavioral intervention that provides tangible rewards for positive behaviors.
CM has substantial evidence of efficacy in reducing smoking and drug use and increasing treatment retention and medication compliance.
The current study will evaluate the efficacy of a 24-week CM intervention to promote weight loss in overweight and obese university students.
Seventy participants with a body mass index (BMI) of 27.0-34.9
will be randomly assigned to one of two conditions: (a) LEARN, a manual guided behavioral weight loss program (Brownell, 2004), with weigh-ins and supportive counseling, or (b) LEARN with weigh-ins and supportive counseling plus CM.
Participants in the CM condition will earn chances to win prizes each week in which they lose at least one pound.
Once they lose 5% of baseline body weight, they will earn chances to win prizes for weight loss or weight maintenance.
Additional chances can be earned by completing activities that promote weight loss.
The primary outcomes will be absolute and proportional weight loss from pre- to post-treatment, as well as proportion of participants achieving clinically significant weight loss (>5% of baseline weight) and proportion moving into a lower risk BMI category.
Secondary outcomes will include length of retention in the study, increase in physical activity level, and improvement in nutritional quality of diet.
Effects of the CM intervention on psychiatric distress and self-efficacy and motivation to engage in activities that promote weight loss will also be assessed.
We predict that participants in the CM condition will lose more weight than participants assigned to the LEARN program without CM, and that more CM participants will achieve clinically significant weight loss.
We also predict that participants in the CM condition will remain in the program longer, show larger increases in physical activity, show greater improvements in diet quality, and have greater increases in levels of self-efficacy and motivation than comparison group participants.
Mediators and moderators of CM outcomes will also be evaluated.
If efficacious in promoting weight loss in a college population, CM could help to prevent or delay later development of obesity-related medical problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
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
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
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
17 years to 29 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- currently enrolled as an undergraduate or graduate student
- age between 17 and 29 years
- body mass index in kg/m2 (BMI) between 27.0 and 39.9
- resting blood pressure between 90-140 (systolic) and 60-90 (diastolic) mmHg
- willingness and ability to participate for 24 weeks from date of enrollment
- willingness to be randomly assigned to one of two groups
Exclusion Criteria:
- serious acute or chronic medical problems (e.g. diabetes mellitus, heart disease, cancer, asthma, back or joint problems, hernias, history of recent surgery)
- pregnant or breast feeding
- current, uncontrolled psychiatric condition or serious psychiatric symptoms (e.g. current suicidality, psychotic symptoms
- meet criteria for a substance dependence disorder, (5) they report daily tobacco use
- any reported history of past or current eating disorders
- in recovery from pathological gambling
- report losing more than 10% of their heaviest body weight in the last 6 months
- report participation in a formal weight loss program in the last 6 months.
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LEARN Program
Participants will receive weekly weight loss counseling based on the LEARN Program for Weight Management.
|
Participants will receive weekly counseling based on the LEARN Program for Weight Management
|
Experimental: LEARN Plus Contingency Management
Participants will receive weekly counseling based on the LEARN Program for Weight Management plus contingency management.
Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.
|
Participants will receive weekly counseling based on the LEARN Program for Weight Management
Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Weight in Pounds
Time Frame: Baseline, 12 weeks, 24 weeks, 1 year
|
Baseline, 12 weeks, 24 weeks, 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Petry, Ph.D., UConn Health
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
February 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (Estimate)
January 21, 2010
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H09-067
- 1R21HL092382-01A2 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Weight Loss
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on LEARN Program
-
Holland Bloorview Kids Rehabilitation HospitalCompleted
-
Herlev HospitalNot yet recruitingMelanoma | Pigmented Lesions
-
Herlev HospitalEnrolling by invitation
-
Herlev HospitalCompleted
-
Vastra Gotaland RegionGöteborg UniversityActive, not recruiting
-
The Reading Hospital and Medical CenterThe Edna G. Kynett Memorial FoundationCompleted
-
University of North Carolina, Chapel HillCompleted
-
University of South CarolinaNational Institute of General Medical Sciences (NIGMS)Not yet recruiting
-
University of TorontoMcMaster UniversityCompletedPhysical Activity | Motor DevelopmentCanada