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Treating Obesity in Underserved Overweight Populations

Treating Obesity and Its Consequences in Underserved Overweight Populations

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00373230
Enrollment
320
Registered
2006-09-07
Start date
2007-10-31
Completion date
2010-02-28
Last updated
2008-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

weight loss, telemedicine, african-american, rural

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.

Interventions

BEHAVIORALtelemedicine

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

Sponsors

Geisinger Clinic
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Insight Telehealth Systems
CollaboratorINDUSTRY
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Diabetes on medications

Design outcomes

Primary

MeasureTime frame
subject's weight3 and 15 months

Secondary

MeasureTime frame
blood lipids3 and 15 months
blood glucose3 and 15 months
A1c3 and 15 months
Use of telemedicine systemover 12 months
blood pressure3 and 15 months
Oral Glucose Tolerance3 and 15 months
Insulin3 and 15 months

Countries

United States

Contacts

Primary ContactCarol Homko, PhD
carol.homko@temple.edu215-707-3784
Backup ContactWilliam P Santamore, PhD
Williamsantamore@hotmail.com215-707-4239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026