MedPath

Treating Obesity in Underserved Overweight Populations

Not Applicable
Conditions
Overweight
Interventions
Behavioral: telemedicine
Registration Number
NCT00373230
Lead Sponsor
Temple University
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".

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
320
Inclusion Criteria
  • 27<BMI<45
  • Able to walk
Exclusion Criteria
  • Diabetes on medications

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1telemedicineInternet based telemedicine weight maintenance program
2telemedicineIn person weight maintenance monthly consultations
Primary Outcome Measures
NameTimeMethod
subject's weight3 and 15 months
Secondary Outcome Measures
NameTimeMethod
Use of telemedicine systemover 12 months
blood lipids3 and 15 months
blood glucose3 and 15 months
A1c3 and 15 months
Insulin3 and 15 months
blood pressure3 and 15 months
Oral Glucose Tolerance3 and 15 months

Trial Locations

Locations (2)

Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

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