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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014