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Contingency Management to Promote Weight Loss in Low Income Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00875199
First received: March 31, 2009
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  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 2

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:

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

  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 May 22, 2013