Treating Obesity in Underserved Overweight Populations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Geisinger Clinic
University of Pennsylvania
Insight Telehealth Systems
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00373230
First received: September 5, 2006
Last updated: October 22, 2008
Last verified: October 2008

September 5, 2006
October 22, 2008
October 2007
February 2010   (final data collection date for primary outcome measure)
subject's weight [ Time Frame: 3 and 15 months ] [ Designated as safety issue: No ]
subjects weight at 16 months
Complete list of historical versions of study NCT00373230 on ClinicalTrials.gov Archive Site
  • Use of telemedicine system [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
  • blood lipids [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
  • blood glucose [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
  • A1c [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
  • Insulin [ Time Frame: 3 and 15 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
  • Oral Glucose Tolerance [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
  • Use of telemedicine system
  • blood lipids
  • blood glucose
  • A1c
  • Insulin
  • blood pressure
  • number of medications
Not Provided
Not Provided
 
Treating Obesity in Underserved Overweight Populations
Treating Obesity and Its Consequences in Underserved Overweight Populations

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.

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".

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Overweight
Behavioral: telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
  • Experimental: 1
    Internet based telemedicine weight maintenance program
    Intervention: Behavioral: telemedicine
  • Active Comparator: 2
    In person weight maintenance monthly consultations
    Intervention: Behavioral: telemedicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 27<BMI<45
  • Able to walk

Exclusion Criteria:

  • Diabetes on medications
Both
18 Years to 75 Years
Yes
Contact: Carol Homko, PhD 215-707-3784 carol.homko@temple.edu
Contact: William P Santamore, PhD 215-707-4239 Williamsantamore@hotmail.com
United States
 
NCT00373230
2005NFGrantTemple
Yes
Guenther Boden, MD, Temple University
Temple University
  • Geisinger Clinic
  • University of Pennsylvania
  • Insight Telehealth Systems
Principal Investigator: Guenther Boden, MD Temple University
Temple University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP