Obesity Clinical Trial
Official title:
A Behavioral Intervention for Reducing Obesity
| NCT number | NCT00892788 |
| Other study ID # | 09-128-1 |
| Secondary ID | 20090200 |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2009 |
| Est. completion date | July 2010 |
| Verified date | April 2019 |
| Source | UConn Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Connecticut Health Center | Farmington | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| UConn Health | UCHC/Storrs and Regional Campus Incentive Grants |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | absolute and relative weight loss | Weeks 1-12 | ||
| Primary | changes in waist circumference | Week 1 and Week 12 | ||
| Primary | proportion of participants achieving clinically significant weight loss (5% or more of baseline weight) | Week 1 and Week 12 | ||
| Secondary | indices of treatment retention | Weeks 1-12 | ||
| Secondary | changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels | Week 1 and Week 12 |
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