Back to resultsManaging Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral weight loss treatment
Weight Watchers
Combined Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- Baruch College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Standard behavioral weight loss
Weight Watchers
Combined Treatment
Arm Description
University-based behavioral weight loss treatment
Weight Watchers program
University-based behavioral weight loss treatment followed by Weight Watchers
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
cost-effectiveness
Full Information
NCT ID
NCT00827593
First Posted
January 22, 2009
Last Updated
April 12, 2012
Sponsor
Baruch College City University of New York
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00827593
Brief Title
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Official Title
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baruch College City University of New York
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard behavioral weight loss
Arm Type
Active Comparator
Arm Description
University-based behavioral weight loss treatment
Arm Title
Weight Watchers
Arm Type
Active Comparator
Arm Description
Weight Watchers program
Arm Title
Combined Treatment
Arm Type
Active Comparator
Arm Description
University-based behavioral weight loss treatment followed by Weight Watchers
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral weight loss treatment
Intervention Description
Participants will receive 12 months of university-based behavioral weight loss treatment
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers
Intervention Description
Participants will receive 12 months of Weight Watchers
Intervention Type
Behavioral
Intervention Name(s)
Combined Treatment
Intervention Description
Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers
Primary Outcome Measure Information:
Title
weight loss
Time Frame
3, 6, 12 months
Secondary Outcome Measure Information:
Title
cost-effectiveness
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Pinto, PhD
Organizational Affiliation
Baruch College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baruch College
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23404824
Citation
Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.
Results Reference
derived
Learn more about this trial
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
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