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Treatment of Obesity in Underserved Rural Settings (TOURS)

University of Florida logo

University of Florida

Status

Completed

Conditions

Obesity

Treatments

Other: Mail contact
Behavioral: Telephone counseling
Behavioral: Face-to-face counseling

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00201006
273
R01HL073326 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

234 patients

Sex

Female

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

BMI between 30 and 45

Exclusion criteria

presence of serious disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

234 participants in 3 patient groups

Face-to-face counseling
Experimental group
Description:
26 biweekly face-to-face group counseling sessions
Treatment:
Behavioral: Face-to-face counseling
Telephone Counseling
Experimental group
Description:
26 biweekly telephone counseling sessions
Treatment:
Behavioral: Telephone counseling
Mail contact
Active Comparator group
Description:
26 biweekly newsletters with weight management advice
Treatment:
Other: Mail contact

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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