A Behavioral Intervention for Reducing Obesity

April 5, 2019 updated by: UConn Health
This study will examine a contingency management (CM) intervention designed to provide incentives for losing weight versus participating in a manual-guided behavioral weight loss intervention alone. Participants in the CM condition will earn the opportunity to win prizes by losing weight and completing activities that contribute to weight loss, such as keeping daily food and physical activity diaries, choosing healthy foods, exercising, and using other weight loss strategies. The investigators will determine if the CM improves weight loss relative to the usual care manual-guided intervention alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

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

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030-3944
        • University of Connecticut Health Center

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 65 years
  • body mass index in kg/m2 (BMI) between 30.0 and 39.9
  • seated blood pressure of 100/60-140/90 mmHg
  • ability to speak English and read at the 6th grade level
  • willingness to be randomly assigned to one of two groups

Exclusion Criteria:

  • any serious acute or chronic medical problems that may impact dietary or exercise regimens or impact weight loss
  • psychiatric exclusions

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: A
Participants assigned to Group A will receive the LEARN (Lifestyle, Exercise, Attitudes, Relationships, Nutrition) Program weight loss manual and will be instructed to read a section of the manual each week and complete suggested activities. They will also meet with the research staff once a week for weigh-in and supportive counseling.
Behavioral: weight loss manual-guided individual therapy sessions
once weekly counseling sessions with research staff
Experimental: B
Participants assigned to Group B will receive the LEARN manual and will meet with research staff each week for weigh-in and supportive counseling. They will also receive contingency management or the opportunity to earn draws with the chance of winning prizes for losing weight and completing healthy activities.
Behavioral: contingency management
Prize-based contingency management for weight loss
Behavioral: weight loss manual-guided individual therapy sessions
once weekly counseling sessions with research staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
absolute and relative weight loss
Time Frame: Weeks 1-12
Weeks 1-12
changes in waist circumference
Time Frame: Week 1 and Week 12
Week 1 and Week 12
proportion of participants achieving clinically significant weight loss (5% or more of baseline weight)
Time Frame: Week 1 and Week 12
Week 1 and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
indices of treatment retention
Time Frame: Weeks 1-12
Weeks 1-12
changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels
Time Frame: Week 1 and Week 12
Week 1 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

UCHC/Storrs and Regional Campus Incentive Grants

Investigators

  • Principal Investigator: Nancy M 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

April 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

May 2, 2009

First Posted (Estimate)

May 5, 2009

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

  • 09-128-1
  • 20090200 (Other Grant/Funding Number: UCHC/Storrs and Regional Campus Incentive Grants)

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.

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