Contingency Management to Promote Weight Loss in Low Income Adults - Full Text View

Sponsor:	University of Connecticut Health Center
Information provided by (Responsible Party):	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00875199

Purpose

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.

Condition	Intervention	Phase
Overweight	Behavioral: contingency management Behavioral: weight loss manual-guided individual therapy sessions	Phase II

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 to Promote Weight Loss in Low Income Adults

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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

Primary Outcome Measures:

absolute and relative weight loss [ Time Frame: pre-treatment, weekly during active phase, post-treatment ] [ Designated as safety issue: No ]
number of participants achieving clinically significant weight loss (5% or more of baseline weight) [ Time Frame: pre-treatment, weekly during active phase, post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

retention [ Time Frame: during active phase ] [ Designated as safety issue: No ]
changes on measures of diet quality, physical activity, and self-efficacy [ Time Frame: pre-treatment, post-treatment ] [ Designated as safety issue: No ]
self-reports, focus groups [ Time Frame: pre-treatment, post-treatment ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A 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.	Behavioral: weight loss manual-guided individual therapy sessions once weekly counseling session with research staff
Experimental: B 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.	Behavioral: contingency management Prize-based contingency management for weight loss

Arms

Assigned Interventions

Active Comparator: A

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.

Behavioral: weight loss manual-guided individual therapy sessions

once weekly counseling session with research staff

Experimental: B

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.

Behavioral: contingency management

Prize-based contingency management for weight loss

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875199

Locations

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030

Sponsors and Collaborators

University of Connecticut Health Center

Investigators

Principal Investigator:

Danielle M Barry, Ph.D.

University of Connecticut Health Center

More Information

No publications provided

Responsible Party:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00875199 History of Changes
Other Study ID Numbers:	09-108-2, 20090009
Study First Received:	March 31, 2009
Last Updated:	November 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:

Overweight
Obesity
Contingency Management

Additional relevant MeSH terms:

Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012