Contingency Management for Promoting Weight Loss in University Students (WeLCoMe)
Primary Purpose
Contingency Management, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LEARN Program
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Contingency Management focused on measuring Contingency Management, Weight Loss
Eligibility Criteria
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.
Sites / Locations
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LEARN Program
LEARN Plus Contingency Management
Arm Description
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 plus contingency management. Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.
Outcomes
Primary Outcome Measures
Change in Weight in Pounds
Secondary Outcome Measures
Full Information
NCT ID
NCT01053260
First Posted
January 19, 2010
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01053260
Brief Title
Contingency Management for Promoting Weight Loss in University Students
Acronym
WeLCoMe
Official Title
Contingency Management for Promoting Weight Loss in University Students
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contingency Management, Weight Loss
Keywords
Contingency Management, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEARN Program
Arm Type
Active Comparator
Arm Description
Participants will receive weekly weight loss counseling based on the LEARN Program for Weight Management.
Arm Title
LEARN Plus Contingency Management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LEARN Program
Intervention Description
Participants will receive weekly counseling based on the LEARN Program for Weight Management
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.
Primary Outcome Measure Information:
Title
Change in Weight in Pounds
Time Frame
Baseline, 12 weeks, 24 weeks, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Petry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
12. IPD Sharing Statement
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Contingency Management for Promoting Weight Loss in University Students
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