Treating Obesity in Underserved Overweight Populations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treating Obesity and Its Consequences in Underserved Overweight Populations

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 27<BMI<45 Able to walk Exclusion Criteria: Diabetes on medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Internet based telemedicine weight maintenance program | Behavioral: telemedicine<br>* One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).<br>|
| Active Comparator: 2<br>In person weight maintenance monthly consultations | Behavioral: telemedicine<br>* One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject's weight |  | 3 and 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of telemedicine system |  | over 12 months | 
| blood lipids |  | 3 and 15 months | 
| blood glucose |  | 3 and 15 months | 
| A1c |  | 3 and 15 months | 
| Insulin |  | 3 and 15 months | 
| blood pressure |  | 3 and 15 months | 
| Oral Glucose Tolerance |  | 3 and 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, telemedicine, african-american, rural