- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827593
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
April 12, 2012 updated by: Angela M Pinto, Baruch College City University of New York
The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
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
-
-
New York
-
New York, New York, United States, 10010
- Baruch College
-
-
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
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 30-65 years
- BMI between 27-50 kg/m2
- Written approval/consent from primary health care provider
Exclusion Criteria:
- Unable to walk 2 blocks without stopping.
- Currently participating in a weight loss program or taking weight loss medication.
- Participated in a weight loss program in the last year
- Took weight loss medication in the last 6 months.
- Participated in Weight Watchers in last 2 years.
- Lost >=5% of body weight during 6 months prior to screening.
- Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
- Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
- Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard behavioral weight loss
University-based behavioral weight loss treatment
|
Participants will receive 12 months of university-based behavioral weight loss treatment
|
Active Comparator: Weight Watchers
Weight Watchers program
|
Participants will receive 12 months of Weight Watchers
|
Active Comparator: Combined Treatment
University-based behavioral weight loss treatment followed by Weight Watchers
|
Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight loss
Time Frame: 3, 6, 12 months
|
3, 6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cost-effectiveness
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Angela M Pinto, PhD, Baruch College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
January 22, 2009
First Submitted That Met QC Criteria
January 22, 2009
First Posted (Estimate)
January 23, 2009
Study Record Updates
Last Update Posted (Estimate)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070601
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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