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Treating Obesity in Underserved Overweight Populations

NCT ID: NCT00373230

Last Updated: 2008-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-02-28

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".

Conditions

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Overweight

Keywords

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weight loss telemedicine african-american rural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Internet based telemedicine weight maintenance program

Group Type EXPERIMENTAL

telemedicine

Intervention Type BEHAVIORAL

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

2

In person weight maintenance monthly consultations

Group Type ACTIVE_COMPARATOR

telemedicine

Intervention Type BEHAVIORAL

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

Interventions

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telemedicine

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 27\<BMI\<45
* Able to walk

Exclusion Criteria

* Diabetes on medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Insight Telehealth Systems

INDUSTRY

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Temple University

Principal Investigators

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Guenther Boden, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Temple University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carol Homko, PhD

Role: CONTACT

Phone: 215-707-3784

Email: [email protected]

William P Santamore, PhD

Role: CONTACT

Phone: 215-707-4239

Email: [email protected]

Facility Contacts

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Timothy McConnell, PhD

Role: primary

Linda Zamora, RN, BSN

Role: primary

Maggie Kerper, RN, BSN

Role: backup

Other Identifiers

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2005NFGrantTemple

Identifier Type: -

Identifier Source: org_study_id