Treatment of Obesity in Underserved Rural Settings (TOURS) (TOURS)

• ClinicalTrials.gov Identifier: NCT00201006
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Results First Posted: March 7, 2014
• Last Update Posted: March 7, 2014
• Sponsor: University of Florida
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Florida

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Face-to-face counseling; Behavioral: Telephone counseling; Other: Mail contact	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Obesity in Underserved Rural Settings (TOURS)
• Study Start Date: June 2003
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Face-to-face counseling; 26 biweekly face-to-face group counseling sessions	Behavioral: Face-to-face counseling; Biweekly group behavioral counseling sessions conducted in a face-to-face format
Experimental: Telephone Counseling; 26 biweekly telephone counseling sessions	Behavioral: Telephone counseling; Biweekly telephone counseling sessions conducted in a one-on-one format
Active Comparator: Mail contact; 26 biweekly newsletters with weight management advice	Other: Mail contact; Biweekly written newsletters with weight management advice delivered via U.S. mail

Outcome Measures

Primary Outcome Measures :

1. Change in Body Weight. [ Time Frame: one year ]
   Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

BMI between 30 and 45

Exclusion criteria:

presence of serious disease

Contacts and Locations

Sponsors and Collaborators

University of Florida

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Michael G Perri, PhD; University of Florida

More Information

Publications of Results:

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00201006
• Other Study ID Numbers: 273; R01HL073326 ( U.S. NIH Grant/Contract )
• First Posted: September 20, 2005
• Results First Posted: March 7, 2014
• Last Update Posted: March 7, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight