Treatment of Obesity in Underserved Rural Settings (TOURS)

NCT ID: NCT00201006

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2008-05-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Face-to-face counseling

26 biweekly face-to-face group counseling sessions

Group Type: EXPERIMENTAL

Face-to-face counseling

Intervention Type: BEHAVIORAL

Biweekly group behavioral counseling sessions conducted in a face-to-face format

Telephone Counseling

26 biweekly telephone counseling sessions

Group Type: EXPERIMENTAL

Telephone counseling

Intervention Type: BEHAVIORAL

Biweekly telephone counseling sessions conducted in a one-on-one format

Mail contact

26 biweekly newsletters with weight management advice

Group Type: ACTIVE_COMPARATOR

Mail contact

Intervention Type: OTHER

Biweekly written newsletters with weight management advice delivered via U.S. mail

Interventions

Face-to-face counseling

Biweekly group behavioral counseling sessions conducted in a face-to-face format

Intervention Type: BEHAVIORAL

Telephone counseling

Biweekly telephone counseling sessions conducted in a one-on-one format

Intervention Type: BEHAVIORAL

Mail contact

Biweekly written newsletters with weight management advice delivered via U.S. mail

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

BMI between 30 and 45

Exclusion Criteria

presence of serious disease

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael G Perri, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

References

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.

Reference Type: RESULT

PMID: 19029500 (View on PubMed)

Other Identifiers

R01HL073326

Identifier Type: NIH

Identifier Source: secondary_id

View Link

273

Identifier Type: -

Identifier Source: org_study_id