NCT00201006

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

January 1, 2014

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Results QC Date

November 2, 2013

Last Update Submit

January 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Face-to-face counseling

EXPERIMENTAL

26 biweekly face-to-face group counseling sessions

Behavioral: Face-to-face counseling

Telephone Counseling

EXPERIMENTAL

26 biweekly telephone counseling sessions

Behavioral: Telephone counseling

Mail contact

ACTIVE COMPARATOR

26 biweekly newsletters with weight management advice

Other: Mail contact

Interventions

Biweekly group behavioral counseling sessions conducted in a face-to-face format

Face-to-face counseling

Biweekly telephone counseling sessions conducted in a one-on-one format

Telephone Counseling

Biweekly written newsletters with weight management advice delivered via U.S. mail

Mail contact

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 30 and 45

You may not qualify if:

  • presence of serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael G. Perri, PhD
Organization
University of Florida

Study Officials

  • Michael G Perri, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 7, 2014

Results First Posted

March 7, 2014

Record last verified: 2014-01