Treatment of Obesity in Underserved Rural Settings (TOURS) (TOURS)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Face-to-face counseling
Telephone counseling
Mail contact
Sponsored by

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion criteria: BMI between 30 and 45 Exclusion criteria: presence of serious disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Face-to-face counseling
Telephone Counseling
Mail contact
Arm Description
26 biweekly face-to-face group counseling sessions
26 biweekly telephone counseling sessions
26 biweekly newsletters with weight management advice
Outcomes
Primary Outcome Measures
Change in Body Weight.
Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.
Secondary Outcome Measures
Full Information
NCT ID
NCT00201006
First Posted
September 12, 2005
Last Updated
January 21, 2014
Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00201006
Brief Title
Treatment of Obesity in Underserved Rural Settings (TOURS)
Acronym
TOURS
Official Title
Treatment of Obesity in Underserved Rural Settings (TOURS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 (e.g., 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" (i.e., academic research) venues rather than in "real world" (i.e., 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-to-face counseling
Arm Type
Experimental
Arm Description
26 biweekly face-to-face group counseling sessions
Arm Title
Telephone Counseling
Arm Type
Experimental
Arm Description
26 biweekly telephone counseling sessions
Arm Title
Mail contact
Arm Type
Active Comparator
Arm Description
26 biweekly newsletters with weight management advice
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face counseling
Intervention Description
Biweekly group behavioral counseling sessions conducted in a face-to-face format
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling
Intervention Description
Biweekly telephone counseling sessions conducted in a one-on-one format
Intervention Type
Other
Intervention Name(s)
Mail contact
Intervention Description
Biweekly written newsletters with weight management advice delivered via U.S. mail
Primary Outcome Measure Information:
Title
Change in Body Weight.
Description
Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
BMI between 30 and 45
Exclusion criteria:
presence of serious disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G Perri, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19029500
Citation
Perri MG, Limacher MC, Durning PE, Janicke DM, Lutes LD, Bobroff LB, Dale MS, Daniels MJ, Radcliff TA, Martin AD. Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial. Arch Intern Med. 2008 Nov 24;168(21):2347-54. doi: 10.1001/archinte.168.21.2347.
Results Reference
result
Learn more about this trial
Treatment of Obesity in Underserved Rural Settings (TOURS)
We'll reach out to this number within 24 hrs