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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201006
First Posted: September 20, 2005
Last Update Posted: March 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida
  Purpose
To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.

Condition Intervention
Obesity Behavioral: Face-to-face counseling Behavioral: Telephone counseling Other: Mail contact

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Obesity in Underserved Rural Settings (TOURS)

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Enrollment: 234
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201006


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:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00201006     History of Changes
Other Study ID Numbers: 273
R01HL073326 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: November 2, 2013
Results First Posted: March 7, 2014
Last Update Posted: March 7, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms