Rural Lifestyle Intervention Treatment Effectiveness Trial (RuralLITE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00912652
First received: May 29, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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
Obesity
Behavioral: lifestyle intervention
Behavioral: Health Education Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rural Lifestyle Intervention Treatment Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • body weight [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • lipid profile [ Time Frame: two years ] [ Designated as safety issue: No ]
  • glycemic control [ Time Frame: two years ] [ Designated as safety issue: No ]
  • High-sensitivity C-reactive protein (hsCRP) [ Time Frame: two years ] [ Designated as safety issue: No ]
  • physical activity [ Time Frame: two-years ] [ Designated as safety issue: No ]
  • physical performance [ Time Frame: two-years ] [ Designated as safety issue: No ]
  • dietary intake [ Time Frame: two-years ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: two-years ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: two-years ] [ Designated as safety issue: No ]

Enrollment: 612
Study Start Date: June 2008
Study Completion Date: June 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Lifestyle Intervention
High intensity group will receive 48 sessions of lifestyle intervention over a two-year period
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.
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.
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.
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.

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 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 United States Department of Agriculture 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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912652

Locations
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
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael G. Perri, Ph.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00912652     History of Changes
Other Study ID Numbers: RuralLITE, R18-HL087800
Study First Received: May 29, 2009
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
obesity
rural health
exercise

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014