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
  Purpose

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.


Condition Intervention
Overweight
Behavioral: telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Obesity and Its Consequences in Underserved Overweight Populations

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • subject's weight [ Time Frame: 3 and 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 320
Study Start Date: October 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Internet based telemedicine weight maintenance program
Behavioral: telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
Active Comparator: 2
In person weight maintenance monthly consultations
Behavioral: telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).

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".

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 27<BMI<45
  • Able to walk

Exclusion Criteria:

  • Diabetes on medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373230

Contacts
Contact: Carol Homko, PhD 215-707-3784 carol.homko@temple.edu
Contact: William P Santamore, PhD 215-707-4239 Williamsantamore@hotmail.com

Locations
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Timothy McConnell, PhD    570-271-8067    tmcconnell@geisinger.edu   
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Linda Zamora, RN, BSN    215-707-9733    zamoralc@temple.edu   
Contact: Maggie Kerper, RN, BSN    215 707-9731    kerpermm@tuhs.temple.edu   
Principal Investigator: Guenther Boden, MD         
Sponsors and Collaborators
Temple University
Geisinger Clinic
University of Pennsylvania
Insight Telehealth Systems
Investigators
Principal Investigator: Guenther Boden, MD Temple University
  More Information

No publications provided

Responsible Party: Guenther Boden, MD, Temple University
ClinicalTrials.gov Identifier: NCT00373230     History of Changes
Other Study ID Numbers: 2005NFGrantTemple
Study First Received: September 5, 2006
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
weight loss
telemedicine
african-american
rural

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014