Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201006
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2005-09-12
Brief Title:
Treatment of Obesity in Underserved Rural Settings TOURS
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Treatment of Obesity in Underserved Rural Settings TOURS
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
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:
TOURS
Brief Summary:
To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties
Detailed Description:
BACKGROUND
The recent dramatic rise in the prevalence of obesity has heightened awareness of the significant impact of overweight physical inactivity and unhealthy eating patterns on the development of chronic diseases and disability While there is little doubt that obesity and associated lifestyle factors eg sedentary lifestyle constitute serious threats to health it is also clear that lifestyle interventions can produce body weight reductions of sufficient magnitude to improve health The existing research is limited however with respect to two important factors specifically its generalizability to underserved populations and the maintenance of treatment effects Most weight-loss trials have consisted of efficacy studies conducted with middle-class participants and delivered in optimal ie academic research venues rather than in real world ie community settings Furthermore the existing literature shows that in the absence of long-term care a regaining of lost weight routinely follows the conclusion of treatment Recent research has shown improved maintenance of lost weight when lifestyle interventions are supplemented with clinic-based follow-up programs Thus the next logical steps in this line of research are a to extend these studies to community settings with underserved populations and b to test promising alternative and potentially more efficient modes of treatment delivery such as follow-up care via telephone-based contacts rather than via in-person clinic visits
DESIGN NARRATIVE
A randomized controlled clinical trial will examine the impact of two maintenance interventions designed to sustain weight lost in lifestyle treatment of obesity The study sample will include 300 obese women ages 50-75 years from medically underserved rural areas in North Central Florida All participants will receive a 6-month lifestyle intervention for weight loss called Phase 1 followed by randomization to one of three 12-month follow-up called Phase 2 programs A a Face-to-Face Office-Based Maintenance Program B a Telephone-Based Maintenance Program or C an Education Comparison Condition Participants will be stratified according to county and to BMI and randomly assigned in groups of 11-12 to one of the two experimental programs or to the comparison condition The experimental maintenance programs are designed to help participants sustain the eating and physical activity patterns needed to maintain lost weight The primary difference between the two maintenance programs is their mode of delivery One will be delivered via an office-based group counseling format the other will be delivered via telephone counseling The education comparison condition will involve a program of print materials on the maintenance of a healthy lifestyle delivered via biweekly newsletters
The recent dramatic rise in the prevalence of obesity has heightened awareness of the significant impact of overweight physical inactivity and unhealthy eating patterns on the development of chronic diseases and disability While there is little doubt that obesity and associated lifestyle factors eg sedentary lifestyle constitute serious threats to health it is also clear that lifestyle interventions can produce body weight reductions of sufficient magnitude to improve health The existing research is limited however with respect to two important factors specifically its generalizability to underserved populations and the maintenance of treatment effects Most weight-loss trials have consisted of efficacy studies conducted with middle-class participants and delivered in optimal ie academic research venues rather than in real world ie community settings Furthermore the existing literature shows that in the absence of long-term care a regaining of lost weight routinely follows the conclusion of treatment Recent research has shown improved maintenance of lost weight when lifestyle interventions are supplemented with clinic-based follow-up programs Thus the next logical steps in this line of research are a to extend these studies to community settings with underserved populations and b to test promising alternative and potentially more efficient modes of treatment delivery such as follow-up care via telephone-based contacts rather than via in-person clinic visits
DESIGN NARRATIVE
A randomized controlled clinical trial will examine the impact of two maintenance interventions designed to sustain weight lost in lifestyle treatment of obesity The study sample will include 300 obese women ages 50-75 years from medically underserved rural areas in North Central Florida All participants will receive a 6-month lifestyle intervention for weight loss called Phase 1 followed by randomization to one of three 12-month follow-up called Phase 2 programs A a Face-to-Face Office-Based Maintenance Program B a Telephone-Based Maintenance Program or C an Education Comparison Condition Participants will be stratified according to county and to BMI and randomly assigned in groups of 11-12 to one of the two experimental programs or to the comparison condition The experimental maintenance programs are designed to help participants sustain the eating and physical activity patterns needed to maintain lost weight The primary difference between the two maintenance programs is their mode of delivery One will be delivered via an office-based group counseling format the other will be delivered via telephone counseling The education comparison condition will involve a program of print materials on the maintenance of a healthy lifestyle delivered via biweekly newsletters
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073326 | NIH | None | httpsreporternihgovquickSearchR01HL073326 |