NCT01053260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

January 19, 2010

Last Update Submit

April 5, 2019

Conditions

Keywords

Contingency ManagementWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Change in Weight in Pounds

    Baseline, 12 weeks, 24 weeks, 1 year

Study Arms (2)

LEARN Program

ACTIVE COMPARATOR

Participants will receive weekly weight loss counseling based on the LEARN Program for Weight Management.

Behavioral: LEARN Program

LEARN Plus Contingency Management

EXPERIMENTAL

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 ProgramBehavioral: Contingency Management

Interventions

LEARN ProgramBEHAVIORAL

Participants will receive weekly counseling based on the LEARN Program for Weight Management

LEARN Plus Contingency ManagementLEARN Program

Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.

LEARN Plus Contingency Management

Eligibility Criteria

Age17 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy Petry, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations