Trial Outcomes & Findings for Treatment of Obesity in Underserved Rural Settings (TOURS) (NCT NCT00201006)

NCT ID: NCT00201006

Last Updated: 2014-03-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 234 participants
• Primary outcome timeframe: one year
• Results posted on: 2014-03-07

Participant Flow

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.

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.

Participant milestones

Measure	Face-to-face Counseling 26 biweekly face-to-face group counseling sessions	Telephone Counseling 26 biweekly telephone counseling sessions	Mail Contact 26 biweekly newsletters with weight management advice
Overall Study STARTED	83	72	79
Overall Study COMPLETED	75	70	75
Overall Study NOT COMPLETED	8	2	4

Reasons for withdrawal

Measure	Face-to-face Counseling 26 biweekly face-to-face group counseling sessions	Telephone Counseling 26 biweekly telephone counseling sessions	Mail Contact 26 biweekly newsletters with weight management advice
Overall Study Withdrawal by Subject	7	2	3
Overall Study Adverse Event	1	0	1

Baseline Characteristics

Treatment of Obesity in Underserved Rural Settings (TOURS)

Baseline characteristics by cohort

Measure	Face-to-face Counseling n=83 Participants 26 biweekly face-to-face group counseling sessions	Telephone Counseling n=72 Participants 26 biweekly telephone counseling sessions	Mail Contact n=79 Participants 26 biweekly newsletters with weight management advice	Total n=234 Participants Total of all reporting groups
Age, Continuous	59.2 years STANDARD_DEVIATION 6.2 • n=5 Participants	59.8 years STANDARD_DEVIATION 6.2 • n=7 Participants	58.6 years STANDARD_DEVIATION 6.0 • n=5 Participants	59.4 years STANDARD_DEVIATION 6.1 • n=4 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	72 Participants n=7 Participants	79 Participants n=5 Participants	234 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	83 participants n=5 Participants	72 participants n=7 Participants	79 participants n=5 Participants	234 participants n=4 Participants
Body weight	97.8 kg STANDARD_DEVIATION 14.3 • n=5 Participants	96.4 kg STANDARD_DEVIATION 16.8 • n=7 Participants	95.0 kg STANDARD_DEVIATION 13.4 • n=5 Participants	96.4 kg STANDARD_DEVIATION 15.6 • n=4 Participants

PRIMARY outcome

Timeframe: one year

Population: 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).

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

Outcome measures

Measure	Face-to-face Counseling n=83 Participants 26 biweekly face-to-face group counseling sessions	Telephone Counseling n=72 Participants 26 biweekly telephone counseling sessions	Mail Contact n=79 Participants 26 biweekly newsletters with weight management advice
Change in Body Weight.	1.2 kg Standard Error 0.6	1.2 kg Standard Error 0.7	3.7 kg Standard Error 0.7

Adverse Events

Face-to-face

Serious events: 21 serious events

Other events: 19 other events

Deaths: 0 deaths

Telephone

Serious events: 20 serious events

Other events: 9 other events

Deaths: 0 deaths

Mail

Serious events: 12 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Face-to-face n=83 participants at risk received 26 biweekly office-based, face-to-face group counseling sessions	Telephone n=72 participants at risk received 26 biweekly individual telephone counseling sessions	Mail n=79 participants at risk received by mail 26 biweekly newsletters with weight management information
Cardiac disorders cardiac symptom	2.4% 2/83 • Number of events 2 • 1 year self-reporting by participants	2.8% 2/72 • Number of events 2 • 1 year self-reporting by participants	0.00% 0/79 • 1 year self-reporting by participants
Vascular disorders circulatory problems	0.00% 0/83 • 1 year self-reporting by participants	0.00% 0/72 • 1 year self-reporting by participants	1.3% 1/79 • Number of events 1 • 1 year self-reporting by participants
Ear and labyrinth disorders ear problems	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	1.4% 1/72 • Number of events 1 • 1 year self-reporting by participants	0.00% 0/79 • 1 year self-reporting by participants
Eye disorders eye problem	0.00% 0/83 • 1 year self-reporting by participants	0.00% 0/72 • 1 year self-reporting by participants	1.3% 1/79 • Number of events 1 • 1 year self-reporting by participants
Reproductive system and breast disorders gynecologic and breast problems	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	1.4% 1/72 • Number of events 1 • 1 year self-reporting by participants	2.5% 2/79 • Number of events 2 • 1 year self-reporting by participants
Renal and urinary disorders kidney problem	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	0.00% 0/72 • 1 year self-reporting by participants	0.00% 0/79 • 1 year self-reporting by participants
Musculoskeletal and connective tissue disorders musculoskeletal injury	16.9% 14/83 • Number of events 14 • 1 year self-reporting by participants	15.3% 11/72 • Number of events 11 • 1 year self-reporting by participants	7.6% 6/79 • Number of events 6 • 1 year self-reporting by participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasm	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	1.4% 1/72 • Number of events 1 • 1 year self-reporting by participants	1.3% 1/79 • Number of events 1 • 1 year self-reporting by participants
Nervous system disorders neurological symptoms	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	2.8% 2/72 • Number of events 2 • 1 year self-reporting by participants	0.00% 0/79 • 1 year self-reporting by participants
Respiratory, thoracic and mediastinal disorders respiratory problem	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	2.8% 2/72 • Number of events 2 • 1 year self-reporting by participants	0.00% 0/79 • 1 year self-reporting by participants
Endocrine disorders thyroid problem	1.2% 1/83 • Number of events 1 • 1 year self-reporting by participants	0.00% 0/72 • 1 year self-reporting by participants	1.3% 1/79 • Number of events 1 • 1 year self-reporting by participants

Other adverse events

Measure	Face-to-face n=83 participants at risk received 26 biweekly office-based, face-to-face group counseling sessions	Telephone n=72 participants at risk received 26 biweekly individual telephone counseling sessions	Mail n=79 participants at risk received by mail 26 biweekly newsletters with weight management information
Musculoskeletal and connective tissue disorders minor musculoskeletal injuries	22.9% 19/83 • Number of events 19 • 1 year self-reporting by participants	12.5% 9/72 • Number of events 9 • 1 year self-reporting by participants	15.2% 12/79 • Number of events 12 • 1 year self-reporting by participants

Additional Information

Michael G. Perri, PhD

University of Florida

Phone: 352 273-6214

Email: mperri@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place