Status:
COMPLETED
Rural Lifestyle Intervention Treatment Effectiveness Trial
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
More and more Americans are becoming overweight. The rates of overweight are especially high in rural areas of the country. Until now, there has been little access to weight management programs in rur...
Detailed Description
Higher rates of obesity, sedentary lifestyle, and coronary heart disease are observed in rural than in non-rural areas of the U.S., yet the treatment of obesity in the rural population has received li...
Eligibility Criteria
Inclusion
- Age: 21 to 75 years
- Body Mass Index: 30 to 45 kg/m\*\*2
Exclusion
- Underlying disease likely to limit lifespan and/or increase risk of interventions:cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV, self-reported tuberculosis or treatment); myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; irritable bowel syndrome; previous bariatric surgery; history of organ transplantation; history of musculoskeletal conditions that limit walking; chronic lung diseases that limit physical activity; and any other condition likely to limit five-year life expectancy.
- Metabolic exclusions: fasting blood glucose \> 125 mg/dl at screening if not known to be diabetic (diabetic patients under active treatment will be enrolled if approved by primary provider); fasting serum triglycerides \> 400 mg/dl at screening; resting blood pressure \> 140/90 mm Hg.
- Medication exclusions: antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or Tuberculosis; chemotherapeutic drugs; or use of prescription weight-loss drugs within six months.
- Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling to travel to Extension office for intervention sessions; participation in another randomized research project; weight loss \> 10 pounds in past six months; likely to move out of the county in next two years; major psychiatric disorder; excessive alcohol intake; BMI \> 45; prior participation in the TOURS trial; and other conditions which in the opinion of staff would adversely affect participation in the trial
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT00912652
Start Date
June 1 2008
End Date
June 1 2014
Last Update
April 5 2018
Active Locations (8)
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1
Levy County
Bronson, Florida, United States, 32621
2
Flagler County
Bunnell, Florida, United States, 32110
3
Dixie County
Cross City, Florida, United States, 32628
4
Putnam County
East Palatka, Florida, United States, 32131