Obesity Treatment in a Managed Care Setting
October 20, 2017 updated by: University of Minnesota
The aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting.
Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition.
Primary outcomes are participation rates in programs, weight change, and cost.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1801
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
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- University of Minnesota, Division of Epidemiology
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- at least 18 years of age
- BMI ≥ 27.8 kg/m2 for men
- BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women
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 |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Mail-based weight loss intervention
|
|
|
Experimental: Telephone-based weight loss intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in body weight
Time Frame: 6 and 12 months
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert W. Jeffery, PhD, University of Minnesota, Division of Epidemiology
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 (Actual)
March 1, 1999
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
June 18, 2003
First Submitted That Met QC Criteria
June 18, 2003
First Posted (Estimate)
June 19, 2003
Study Record Updates
Last Update Posted (Actual)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBMANC (completed)
- R01DK053826 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.