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A Behavioral Intervention for Reducing Obesity

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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.

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.

Outcomes

Primary Outcome Measures

absolute and relative weight loss
changes in waist circumference
proportion of participants achieving clinically significant weight loss (5% or more of baseline weight)

Secondary Outcome Measures

indices of treatment retention
changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels

Full Information

First Posted
April 3, 2009
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
UCHC/Storrs and Regional Campus Incentive Grants
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1. Study Identification

Unique Protocol Identification Number
NCT00892788
Brief Title
A Behavioral Intervention for Reducing Obesity
Official Title
A Behavioral Intervention for Reducing Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
UCHC/Storrs and Regional Campus Incentive Grants

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
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 sessions with research staff
Primary Outcome Measure Information:
Title
absolute and relative weight loss
Time Frame
Weeks 1-12
Title
changes in waist circumference
Time Frame
Week 1 and Week 12
Title
proportion of participants achieving clinically significant weight loss (5% or more of baseline weight)
Time Frame
Week 1 and Week 12
Secondary Outcome Measure Information:
Title
indices of treatment retention
Time Frame
Weeks 1-12
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, 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
06030-3944
Country
United States

12. IPD Sharing Statement

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A Behavioral Intervention for Reducing Obesity

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