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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00912652 |
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 rural areas. This study will examine ways to help individuals from rural counties to manage weight and improve fitness. To do this, three doses of lifestyle treatment (Low, Moderate and High)will be compared to an education control condition.
Our principal hypothesis is that both the Moderate and High conditions will have greater weight loss at two years than either the Low or Control conditions.
Condition | Intervention |
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Obesity |
Behavioral: lifestyle intervention Behavioral: Health Education Control |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Rural Lifestyle Intervention Treatment Effectiveness Trial |
Estimated Enrollment: | 542 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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High Intensity Lifestyle Intervention: Experimental
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.
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Mod. Intensity Lifestyle Intervention: Experimental
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.
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Low Intensity Lifestyle Intervention: Experimental
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.
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Health Education Control: Active Comparator
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.
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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 little attention. Efficacy trials, conducted in academic health centers, show that lifestyle interventions can produce sufficient weight reductions to improve health, but very few trials have been carried out in medically underserved community settings. Moreover, the high intensity of treatments used in efficacy studies represents a barrier to dissemination into rural settings. The existing infrastructure of the USDA Cooperative Extension Service, with over 2900 offices nationwide, may serve as a valuable resource for bringing lifestyle interventions to rural areas. Preliminary data from our rural obesity research program show promising findings for lifestyle interventions delivered through Extension offices. The next logical step in this line of research is to determine the minimum intensity of treatment required to produce clinically meaningful, long-term weight reductions. We propose to conduct a single-blind, multi-site, randomized controlled trial in obese adults (N=542) to evaluate the effects of LOW, MODERATE, and HIGH doses of lifestyle treatment on two-year changes in body weight, compared to an education CONTROL condition. The LOW intensity condition reflects the dose of group treatment commonly used in community settings, whereas the HIGH dose corresponds to the intensity level employed in efficacy trials. The MODERATE intensity intervention represents a treatment dose that our preliminary data suggest may provide benefits comparable to the HIGH intensity intervention. Our principal hypothesis is that both the MODERATE and HIGH interventions will produce greater weight reductions at two years than either the LOW or CONTROL conditions.
We will also evaluate the proportion of participants in each condition, who achieve clinically significant weight losses, and we will examine changes in metabolic risk factors, dietary intake, physical activity, and quality of life. We will calculate the cost-effectiveness of the interventions, and we will investigate potential mediators of long-term change.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael G. Perri, Ph.D. | 352/273-6214 | mperri@phhp.ufl.edu |
United States, Florida | |
Baker County | Recruiting |
Macclenny, Florida, United States, 32063 | |
Dixie County | Recruiting |
Cross City, Florida, United States, 32628 | |
Lafayette County | Recruiting |
Mayo, Florida, United States, 32066 | |
Levy County | Recruiting |
Bronson, Florida, United States, 32621 | |
Suwannee County | Active, not recruiting |
Live Oak, Florida, United States, 32064 | |
Flagler County | Active, not recruiting |
Bunnell, Florida, United States, 32110 | |
Putnam County | Active, not recruiting |
East Palatka, Florida, United States, 32131 | |
Bradford County | Active, not recruiting |
Starke, Florida, United States, 32091 |
Principal Investigator: | Michael G. Perri, Ph.D. | University of Florida |
Responsible Party: | University of Florida ( Michael G. Perri/Interim Dean and Associate Dean for Research ) |
Study ID Numbers: | RuralLITE, R18-HL087800 |
Study First Received: | May 29, 2009 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00912652 History of Changes |
Health Authority: | United States: Institutional Review Board |
obesity rural health exercise |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |