Treatment of Obesity in Underserved Rural Settings (TOURS)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Intervention name(s): Face-to-face counseling; Telephone counseling; Mail contact
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Biweekly group behavioral counseling sessions conducted in a face-to-face format; Biweekly telephone counseling sessions conducted in a one-on-one format; Biweekly written newsletters with weight management advice delivered via U.S. mail
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment