- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875199
Contingency Management to Promote Weight Loss in Low Income Adults
November 17, 2011 updated by: UConn Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Prize-based contingency management for weight loss
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
absolute and relative weight loss
Time Frame: pre-treatment, weekly during active phase, post-treatment
|
pre-treatment, weekly during active phase, post-treatment
|
|
number of participants achieving clinically significant weight loss (5% or more of baseline weight)
Time Frame: pre-treatment, weekly during active phase, post-treatment
|
pre-treatment, weekly during active phase, post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
retention
Time Frame: during active phase
|
during active phase
|
|
changes on measures of diet quality, physical activity, and self-efficacy
Time Frame: pre-treatment, post-treatment
|
pre-treatment, post-treatment
|
|
self-reports, focus groups
Time Frame: pre-treatment, post-treatment
|
pre-treatment, post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle M Barry, Ph.D., UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (ESTIMATE)
April 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2011
Last Update Submitted That Met QC Criteria
November 17, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-108-2
- 20090009 (OTHER_GRANT: The Ethel Donaghue Center for Translating Research into Practice and Policy)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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