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

Intervention / Treatment

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

  • United States
    • 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
Behavioral: Standard behavioral weight loss treatment
Participants will receive 12 months of university-based behavioral weight loss treatment
Active Comparator: Weight Watchers
Weight Watchers program
Behavioral: Weight Watchers
Participants will receive 12 months of Weight Watchers
Active Comparator: Combined Treatment
University-based behavioral weight loss treatment followed by Weight Watchers
Behavioral: Combined Treatment
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.

Sponsor

Baruch College City University of New York

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

General Publications

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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