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Contingency Management to Promote Weight Loss in Low Income Adults

Primary Purpose

Overweight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
contingency management
weight loss manual-guided individual therapy sessions
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Contingency Management

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 and 55 years
  • body mass index in kg/m2 (BMI) between 25 and 39.9
  • resting blood pressure between 90/60 and 140/90
  • 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
  • psychiatric conditions

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Participants assigned to Group A will receive the DPP manual (Wing & Gillis, 1996), a behavioral weight-loss program with demonstrated efficacy in facilitating weight loss. Participants in Group A 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.

Participants assigned to Group B will receive the DPP 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.

Outcomes

Primary Outcome Measures

absolute and relative weight loss
number of participants achieving clinically significant weight loss (5% or more of baseline weight)

Secondary Outcome Measures

retention
changes on measures of diet quality, physical activity, and self-efficacy
self-reports, focus groups

Full Information

First Posted
March 31, 2009
Last Updated
November 17, 2011
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT00875199
Brief Title
Contingency Management to Promote Weight Loss in Low Income Adults
Official Title
Contingency Management to Promote Weight Loss in Low Income Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. The study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Overweight, Obesity, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Participants assigned to Group A will receive the DPP manual (Wing & Gillis, 1996), a behavioral weight-loss program with demonstrated efficacy in facilitating weight loss. Participants in Group A 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.
Arm Title
B
Arm Type
Experimental
Arm Description
Participants assigned to Group B will receive the DPP 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.
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
Prize-based contingency management for weight loss
Intervention Type
Behavioral
Intervention Name(s)
weight loss manual-guided individual therapy sessions
Intervention Description
once weekly counseling session with research staff
Primary Outcome Measure Information:
Title
absolute and relative weight loss
Time Frame
pre-treatment, weekly during active phase, post-treatment
Title
number of participants achieving clinically significant weight loss (5% or more of baseline weight)
Time Frame
pre-treatment, weekly during active phase, post-treatment
Secondary Outcome Measure Information:
Title
retention
Time Frame
during active phase
Title
changes on measures of diet quality, physical activity, and self-efficacy
Time Frame
pre-treatment, post-treatment
Title
self-reports, focus groups
Time Frame
pre-treatment, post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 55 years body mass index in kg/m2 (BMI) between 25 and 39.9 resting blood pressure between 90/60 and 140/90 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 psychiatric conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle M Barry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Contingency Management to Promote Weight Loss in Low Income Adults

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