Treatment of Obesity in Underserved Rural Settings (TOURS)

Study Overview
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Brief Summary
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To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Face-to-face counseling
* Behavioral: Telephone counseling
* Other: Mail contact


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: BMI between 30 and 45 Exclusion criteria: presence of serious disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight. | Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity. | one year |