A Behavioral Intervention for Reducing Obesity - Full Text View

Sponsor:	University of Connecticut Health Center
Collaborator:	UCHC/Storrs and Regional Campus Incentive Grants
Information provided by:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00892788

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Behavioral Intervention for Reducing Obesity

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: Weeks 1-12 ] [ Designated as safety issue: No ]
changes in waist circumference [ Time Frame: Week 1 and Week 12 ] [ Designated as safety issue: No ]
proportion of participants achieving clinically significant weight loss (5% or more of baseline weight) [ Time Frame: Week 1 and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

indices of treatment retention [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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
B: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892788

Contacts

Contact: Ellen M Ciesielski, B.A.

860.679.4556

eciesielski@uchc.edu

Locations

United States, Connecticut
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030-3944
Contact: Ellen M Ciesielski, B.A. 860-679-4556 eciesielski@uchc.edu
Principal Investigator: Nancy M Petry, Ph.D.
Sub-Investigator: Danielle M Barry, Ph.D.
Sub-Investigator: Rafael Perez-Escamilla, Ph.D.
Sub-Investigator: William White, M.D.
Sub-Investigator: Linda Pescatello, Ph.D.

Sponsors and Collaborators

University of Connecticut Health Center

UCHC/Storrs and Regional Campus Incentive Grants

Investigators

Principal Investigator:

Nancy M Petry, Ph.D.

University of Connecticut Health Center

More Information

No publications provided

Responsible Party:	University of Connecticut Health Center ( Nancy Petry, Ph.D. )
Study ID Numbers:	09-128-1, 20090200
Study First Received:	April 3, 2009
Last Updated:	October 3, 2009
ClinicalTrials.gov Identifier:	NCT00892788 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:

Overweight
Obesity
Contingency Management

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on February 08, 2010