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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
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contingency Management focused on measuring Contingency Management, Weight Loss

Eligibility Criteria

17 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 19, 2010
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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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