Back to resultsObesity Treatment in a Managed Care Setting
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mail-based weight loss intervention
Phone-based weight loss intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity treatment, weight management, managed care
Eligibility Criteria
at least 18 years of age BMI ≥ 27.8 kg/m2 for men BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women
Sites / Locations
- University of Minnesota, Division of Epidemiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Mail-based weight loss intervention
Telephone-based weight loss intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Full Information
NCT ID
NCT00062985
First Posted
June 18, 2003
Last Updated
October 20, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00062985
Brief Title
Obesity Treatment in a Managed Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 1999 (Actual)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
obesity treatment, weight management, managed care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Mail-based weight loss intervention
Arm Type
Experimental
Arm Title
Telephone-based weight loss intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mail-based weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
Phone-based weight loss intervention
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
at least 18 years of age
BMI ≥ 27.8 kg/m2 for men
BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W. Jeffery, PhD
Organizational Affiliation
University of Minnesota, Division of Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, Division of Epidemiology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14517547
Citation
Jeffery RW, Sherwood NE, Brelje K, Pronk NP, Boyle R, Boucher JL, Hase K. Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1584-92. doi: 10.1038/sj.ijo.0802473.
Results Reference
result
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Obesity Treatment in a Managed Care Setting
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