Rural Lifestyle Intervention Treatment Effectiveness Trial (RuralLITE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00912652 |
Recruitment Status :
Completed
First Posted : June 3, 2009
Last Update Posted : April 5, 2018
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Behavioral: lifestyle intervention Behavioral: Health Education Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 612 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Rural Lifestyle Intervention Treatment Effectiveness Trial |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: High Intensity Lifestyle Intervention
High intensity group will receive 48 sessions of lifestyle intervention over a two-year period
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Behavioral: lifestyle intervention
Three doses of lifestyle intervention will be compared to an education control condition. |
Experimental: Mod. Intensity Lifestyle Intervention
Moderate intensity group will receive 32 sessions of lifestyle intervention over a two-year period.
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Behavioral: lifestyle intervention
Three doses of lifestyle intervention will be compared to an education control condition. |
Experimental: Low Intensity Lifestyle Intervention
Low intensity group will receive 16 sessions of lifestyle intervention over a two-year period.
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Behavioral: lifestyle intervention
Three doses of lifestyle intervention will be compared to an education control condition. |
Active Comparator: Health Education Control
Health education control group will receive 16 sessions of health education related to diet and exercise over a two-year period.
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Behavioral: Health Education Control
Health education control group will receive 16 session of health education related to diet and exercise over a two-year period. |
- body weight [ Time Frame: two years ]
- blood pressure [ Time Frame: two years ]
- lipid profile [ Time Frame: two years ]
- glycemic control [ Time Frame: two years ]
- High-sensitivity C-reactive protein (hsCRP) [ Time Frame: two years ]
- physical activity [ Time Frame: two-years ]
- physical performance [ Time Frame: two-years ]
- dietary intake [ Time Frame: two-years ]
- waist circumference [ Time Frame: two-years ]
- health-related quality of life [ Time Frame: two-years ]

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 21 to 75 years
- Body Mass Index: 30 to 45 kg/m**2
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912652
United States, Florida | |
Levy County | |
Bronson, Florida, United States, 32621 | |
Flagler County | |
Bunnell, Florida, United States, 32110 | |
Dixie County | |
Cross City, Florida, United States, 32628 | |
Putnam County | |
East Palatka, Florida, United States, 32131 | |
Suwannee County | |
Live Oak, Florida, United States, 32064 | |
Baker County | |
Macclenny, Florida, United States, 32063 | |
Lafayette County | |
Mayo, Florida, United States, 32066 | |
Bradford County | |
Starke, Florida, United States, 32091 |
Principal Investigator: | Michael G. Perri, Ph.D. | University of Florida |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00912652 History of Changes |
Other Study ID Numbers: |
RuralLITE-N R18HL087800 ( U.S. NIH Grant/Contract ) |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | April 5, 2018 |
Last Verified: | April 2018 |
obesity rural health exercise |
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |