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Trial record 30 of 1373 for:    rural

Rural Lifestyle Intervention Treatment Effectiveness Trial (RuralLITE)

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ClinicalTrials.gov Identifier: NCT00912652
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 29, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
body weight [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00912652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • blood pressure [ Time Frame: two years ]
  • lipid profile [ Time Frame: two years ]
  • glycemic control [ Time Frame: two years ]
  • hsCRP (high-sensitivity C-reactive protein) [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rural Lifestyle Intervention Treatment Effectiveness Trial
Official Title  ICMJE Rural Lifestyle Intervention Treatment Effectiveness Trial
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: lifestyle intervention
    Three doses of lifestyle intervention will be compared to an education control condition.
  • 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.
Study Arms  ICMJE
  • Experimental: High Intensity Lifestyle Intervention
    High intensity group will receive 48 sessions of lifestyle intervention over a two-year period
    Intervention: Behavioral: lifestyle intervention
  • Experimental: Mod. Intensity Lifestyle Intervention
    Moderate intensity group will receive 32 sessions of lifestyle intervention over a two-year period.
    Intervention: Behavioral: lifestyle intervention
  • Experimental: Low Intensity Lifestyle Intervention
    Low intensity group will receive 16 sessions of lifestyle intervention over a two-year period.
    Intervention: Behavioral: lifestyle intervention
  • 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.
    Intervention: Behavioral: Health Education Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
612
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
542
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912652
Other Study ID Numbers  ICMJE RuralLITE-N
R18HL087800 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Michael G. Perri, Ph.D. University of Florida
PRS Account University of Florida
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP