Treating Obesity in Underserved Overweight Populations

Overweight Clinical Trial

Official title:

Treating Obesity and Its Consequences in Underserved Overweight Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00373230
• Other study ID #: 2005NFGrantTemple
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2006
• Last updated: October 22, 2008
• Start date: October 2007
• Est. completion date: February 2010

Study information

• Verified date: October 2008
• Source: Temple University
• Contact: Carol Homko, PhD
• Phone: 215-707-3784
• Email: carol.homko[@]temple.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 27<BMI<45

• Able to walk

Exclusion Criteria:

• Diabetes on medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Temple University	Geisinger Clinic, Insight Telehealth Systems, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subject's weight		3 and 15 months	No
Secondary	Use of telemedicine system		over 12 months	No
Secondary	blood lipids		3 and 15 months	Yes
Secondary	blood glucose		3 and 15 months	Yes
Secondary	A1c		3 and 15 months	Yes
Secondary	Insulin		3 and 15 months	No
Secondary	blood pressure		3 and 15 months	Yes
Secondary	Oral Glucose Tolerance		3 and 15 months	Yes