Contingency Management for Promoting Weight Loss in University Students (WeLCoMe)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01053260
First received: January 19, 2010
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Contingency Management
Weight Loss
Behavioral: LEARN Program
Behavioral: Contingency Management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contingency Management for Promoting Weight Loss in University Students

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Change in Weight in Pounds [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LEARN Program
Participants will receive weekly weight loss counseling based on the LEARN Program for Weight Management.
Behavioral: LEARN Program
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.
Behavioral: LEARN Program
Participants will receive weekly counseling based on the LEARN Program for Weight Management
Behavioral: Contingency Management
Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.

  Eligibility

Ages Eligible for Study:   17 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053260

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy Petry, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01053260     History of Changes
Other Study ID Numbers: H09-067, 1R21HL092382-01A2
Study First Received: January 19, 2010
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Contingency Management
Weight Loss

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014