Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373230
Status:
UNKNOWN
Last Update Posted:
2008-10-23
First Post:
2006-09-05
Brief Title:
Treating Obesity in Underserved Overweight Populations
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Treating Obesity and Its Consequences in Underserved Overweight Populations
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 147 in 1991 to 240 in 2002 and annual medical expenditures attributable to obesity are estimated at 42 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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None