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

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ClinicalTrials.gov Identifier: NCT00201006
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Interventions Behavioral: Face-to-face counseling
Behavioral: Telephone counseling
Other: Mail contact
Enrollment 234
Recruitment Details Study announcements were mailed to households in 6 rural counties in northern Florida designated in whole or in part as health professional shortage areas. Women who responded to the announcements were invited to an orientation/screening session wherein informed consent was obtained. Height and weight were measured by a registered nurse.
Pre-assignment Details 298 women participated in a standard 6-month lifestyle modification program for weight loss, delivered in groups at Cooperative Extension Offices. Eligibility for randomization required completion of the 6-month lifestyle program; 234 completed the initial treatment and were assigned randomly to one of the three extended care conditions.
Arm/Group Title Face-to-face Counseling Telephone Counseling Mail Contact
Hide Arm/Group Description 26 biweekly face-to-face group counseling sessions 26 biweekly telephone counseling sessions 26 biweekly newsletters with weight management advice
Period Title: Overall Study
Started 83 72 79
Completed 75 70 75
Not Completed 8 2 4
Reason Not Completed
Withdrawal by Subject             7             2             3
Adverse Event             1             0             1
Arm/Group Title Face-to-face Counseling Telephone Counseling Mail Contact Total
Hide Arm/Group Description 26 biweekly face-to-face group counseling sessions 26 biweekly telephone counseling sessions 26 biweekly newsletters with weight management advice Total of all reporting groups
Overall Number of Baseline Participants 83 72 79 234
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 72 participants 79 participants 234 participants
59.2  (6.2) 59.8  (6.2) 58.6  (6.0) 59.4  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 72 participants 79 participants 234 participants
Female
83
 100.0%
72
 100.0%
79
 100.0%
234
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 83 participants 72 participants 79 participants 234 participants
83 72 79 234
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 83 participants 72 participants 79 participants 234 participants
97.8  (14.3) 96.4  (16.8) 95.0  (13.4) 96.4  (15.6)
1.Primary Outcome
Title Change in Body Weight.
Hide Description Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month).
Arm/Group Title Face-to-face Counseling Telephone Counseling Mail Contact
Hide Arm/Group Description:
26 biweekly face-to-face group counseling sessions
26 biweekly telephone counseling sessions
26 biweekly newsletters with weight management advice
Overall Number of Participants Analyzed 83 72 79
Mean (Standard Error)
Unit of Measure: kg
1.2  (0.6) 1.2  (0.7) 3.7  (0.7)
Time Frame 1 year
Adverse Event Reporting Description self-reporting by participants
 
Arm/Group Title Face-to-face Telephone Mail
Hide Arm/Group Description received 26 biweekly office-based, face-to-face group counseling sessions received 26 biweekly individual telephone counseling sessions received by mail 26 biweekly newsletters with weight management information
All-Cause Mortality
Face-to-face Telephone Mail
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Face-to-face Telephone Mail
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/83 (25.30%)      20/72 (27.78%)      12/79 (15.19%)    
Cardiac disorders       
cardiac symptom *  2/83 (2.41%)  2 2/72 (2.78%)  2 0/79 (0.00%)  0
Ear and labyrinth disorders       
ear problems *  1/83 (1.20%)  1 1/72 (1.39%)  1 0/79 (0.00%)  0
Endocrine disorders       
thyroid problem *  1/83 (1.20%)  1 0/72 (0.00%)  0 1/79 (1.27%)  1
Eye disorders       
eye problem *  0/83 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1
Musculoskeletal and connective tissue disorders       
musculoskeletal injury *  14/83 (16.87%)  14 11/72 (15.28%)  11 6/79 (7.59%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
neoplasm *  1/83 (1.20%)  1 1/72 (1.39%)  1 1/79 (1.27%)  1
Nervous system disorders       
neurological symptoms *  1/83 (1.20%)  1 2/72 (2.78%)  2 0/79 (0.00%)  0
Renal and urinary disorders       
kidney problem *  1/83 (1.20%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0
Reproductive system and breast disorders       
gynecologic and breast problems *  1/83 (1.20%)  1 1/72 (1.39%)  1 2/79 (2.53%)  2
Respiratory, thoracic and mediastinal disorders       
respiratory problem *  1/83 (1.20%)  1 2/72 (2.78%)  2 0/79 (0.00%)  0
Vascular disorders       
circulatory problems *  0/83 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Face-to-face Telephone Mail
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/83 (22.89%)      9/72 (12.50%)      12/79 (15.19%)    
Musculoskeletal and connective tissue disorders       
minor musculoskeletal injuries *  19/83 (22.89%)  19 9/72 (12.50%)  9 12/79 (15.19%)  12
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael G. Perri, PhD
Organization: University of Florida
Phone: 352 273-6214
EMail: mperri@ufl.edu
Layout table for additonal information
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