search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Face-to-face counseling
Telephone counseling
Mail contact
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Face-to-face counseling

    Telephone Counseling

    Mail contact

    Arm Description

    26 biweekly face-to-face group counseling sessions

    26 biweekly telephone counseling sessions

    26 biweekly newsletters with weight management advice

    Outcomes

    Primary Outcome Measures

    Change in Body Weight.
    Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    January 21, 2014
    Sponsor
    University of Florida
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00201006
    Brief Title
    Treatment of Obesity in Underserved Rural Settings (TOURS)
    Acronym
    TOURS
    Official Title
    Treatment of Obesity in Underserved Rural Settings (TOURS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    234 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Face-to-face counseling
    Arm Type
    Experimental
    Arm Description
    26 biweekly face-to-face group counseling sessions
    Arm Title
    Telephone Counseling
    Arm Type
    Experimental
    Arm Description
    26 biweekly telephone counseling sessions
    Arm Title
    Mail contact
    Arm Type
    Active Comparator
    Arm Description
    26 biweekly newsletters with weight management advice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Face-to-face counseling
    Intervention Description
    Biweekly group behavioral counseling sessions conducted in a face-to-face format
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telephone counseling
    Intervention Description
    Biweekly telephone counseling sessions conducted in a one-on-one format
    Intervention Type
    Other
    Intervention Name(s)
    Mail contact
    Intervention Description
    Biweekly written newsletters with weight management advice delivered via U.S. mail
    Primary Outcome Measure Information:
    Title
    Change in Body Weight.
    Description
    Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: BMI between 30 and 45 Exclusion criteria: presence of serious disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael G Perri, PhD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19029500
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Treatment of Obesity in Underserved Rural Settings (TOURS)

    We'll reach out to this number within 24 hrs