Treating Obesity in Underserved Overweight Populations
Primary Purpose
Overweight
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telemedicine
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring weight loss, telemedicine, african-american, rural
Eligibility Criteria
Inclusion Criteria:
- 27<BMI<45
- Able to walk
Exclusion Criteria:
- Diabetes on medications
Sites / Locations
- Geisinger Medical CenterRecruiting
- Temple UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Internet based telemedicine weight maintenance program
In person weight maintenance monthly consultations
Outcomes
Primary Outcome Measures
subject's weight
Secondary Outcome Measures
Use of telemedicine system
blood lipids
blood glucose
A1c
Insulin
blood pressure
Oral Glucose Tolerance
Full Information
NCT ID
NCT00373230
First Posted
September 5, 2006
Last Updated
October 22, 2008
Sponsor
Temple University
Collaborators
Geisinger Clinic, University of Pennsylvania, Insight Telehealth Systems
1. Study Identification
Unique Protocol Identification Number
NCT00373230
Brief Title
Treating Obesity in Underserved Overweight Populations
Official Title
Treating Obesity and Its Consequences in Underserved Overweight Populations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Temple University
Collaborators
Geisinger Clinic, University of Pennsylvania, Insight Telehealth Systems
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are the focus of this application, which will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Telemedicine will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail.
Detailed Description
Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Ethnic minorities are disproportionately affected with 37% of African-American adults being obese. Obesity is also inversely related to socioeconomic status. In Pennsylvania, the prevalence of obesity increased from 14.7% in 1991 to 24.0% in 2002, and annual medical expenditures attributable to obesity are estimated at $4.2 billion; making Pennsylvania the 4th highest state in the country in terms of obesity-related costs. The prevalence of obesity is matched by it serious medical consequences including type 2 diabetes, hypertension, dyslipidemia, and atherosclerotic disease. The core pathogenetic factor underlying these conditions appears to be insulin resistance. Weight loss through diet and physical activity is the most desirable way to reduce insulin resistance (IR). Weight losses of 8-10% are associated with significant improvements in IR. While clinic-based weight loss programs at tertiary medical centers can produce clinically significant losses, the cost and location of these programs make them inaccessible to underserved populations (e.g., inner city African Americans and rural poor) who are most in need. Moreover, the most common outcome for weight loss treatments is weight regain. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are a priority for research and the focus of this application.
Based on our expertise in behavioral weight management and telemedicine, this study will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Overweight and obese men and women (n = 400) will participate in a 16-week behavioral weight loss program in local churches and community centers. After 16 weeks, participants will be randomized to either an "In-person" follow-up group or to a "telemedicine" group for 1-year. The latter will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail. Assessments of body weight, body composition and insulin sensitivity will be conducted at baseline, 16 and 68 weeks. Based on recent data, we predict greater maintenance of weight loss (and lower body weights) at 68 weeks in the Telemedicine group as compared to the "In person group".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
weight loss, telemedicine, african-american, rural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Internet based telemedicine weight maintenance program
Arm Title
2
Arm Type
Active Comparator
Arm Description
In person weight maintenance monthly consultations
Intervention Type
Behavioral
Intervention Name(s)
telemedicine
Intervention Description
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
Primary Outcome Measure Information:
Title
subject's weight
Time Frame
3 and 15 months
Secondary Outcome Measure Information:
Title
Use of telemedicine system
Time Frame
over 12 months
Title
blood lipids
Time Frame
3 and 15 months
Title
blood glucose
Time Frame
3 and 15 months
Title
A1c
Time Frame
3 and 15 months
Title
Insulin
Time Frame
3 and 15 months
Title
blood pressure
Time Frame
3 and 15 months
Title
Oral Glucose Tolerance
Time Frame
3 and 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
27<BMI<45
Able to walk
Exclusion Criteria:
Diabetes on medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Homko, PhD
Phone
215-707-3784
Email
carol.homko@temple.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William P Santamore, PhD
Phone
215-707-4239
Email
Williamsantamore@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenther Boden, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy McConnell, PhD
Phone
570-271-8067
Email
tmcconnell@geisinger.edu
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zamora, RN, BSN
Phone
215-707-9733
Email
zamoralc@temple.edu
First Name & Middle Initial & Last Name & Degree
Maggie Kerper, RN, BSN
Phone
215 707-9731
Email
kerpermm@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Guenther Boden, MD
12. IPD Sharing Statement
Learn more about this trial
Treating Obesity in Underserved Overweight Populations
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