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Treating Obesity in Underserved Overweight Populations

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Temple University

Status

Unknown

Conditions

Overweight

Treatments

Behavioral: telemedicine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00373230
2005NFGrantTemple

Details and patient eligibility

About

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.

Full 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".

Enrollment

320 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 27<BMI<45
  • Able to walk

Exclusion criteria

  • Diabetes on medications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

1
Experimental group
Description:
Internet based telemedicine weight maintenance program
Treatment:
Behavioral: telemedicine
2
Active Comparator group
Description:
In person weight maintenance monthly consultations
Treatment:
Behavioral: telemedicine

Trial contacts and locations

2

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Central trial contact

Carol Homko, PhD; William P Santamore, PhD

Data sourced from clinicaltrials.gov

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