Treating Obesity in Underserved Overweight Populations
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Overweight |
Behavioral: telemedicine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treating Obesity and Its Consequences in Underserved Overweight Populations |
- subject's weight [ Time Frame: 3 and 15 months ] [ Designated as safety issue: No ]
- Use of telemedicine system [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
- blood lipids [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
- blood glucose [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
- A1c [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
- Insulin [ Time Frame: 3 and 15 months ] [ Designated as safety issue: No ]
- blood pressure [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
- Oral Glucose Tolerance [ Time Frame: 3 and 15 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 320 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Internet based telemedicine weight maintenance program
|
Behavioral: telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
|
|
Active Comparator: 2
In person weight maintenance monthly consultations
|
Behavioral: telemedicine
One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
|
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".
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 27<BMI<45
- Able to walk
Exclusion Criteria:
- Diabetes on medications
Contacts and Locations| Contact: Carol Homko, PhD | 215-707-3784 | carol.homko@temple.edu |
| Contact: William P Santamore, PhD | 215-707-4239 | Williamsantamore@hotmail.com |
| United States, Pennsylvania | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Timothy McConnell, PhD 570-271-8067 tmcconnell@geisinger.edu | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Linda Zamora, RN, BSN 215-707-9733 zamoralc@temple.edu | |
| Contact: Maggie Kerper, RN, BSN 215 707-9731 kerpermm@tuhs.temple.edu | |
| Principal Investigator: Guenther Boden, MD | |
| Principal Investigator: | Guenther Boden, MD | Temple University |
More Information
No publications provided
| Responsible Party: | Guenther Boden, MD, Temple University |
| ClinicalTrials.gov Identifier: | NCT00373230 History of Changes |
| Other Study ID Numbers: | 2005NFGrantTemple |
| Study First Received: | September 5, 2006 |
| Last Updated: | October 22, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Temple University:
|
weight loss telemedicine african-american rural |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013