Rural Lifestyle Intervention Treatment Effectiveness Trial (RuralLITE)

April 4, 2018 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

612

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bronson, Florida, United States, 32621
        • Levy County
      • Bunnell, Florida, United States, 32110
        • Flagler County
      • Cross City, Florida, United States, 32628
        • Dixie County
      • East Palatka, Florida, United States, 32131
        • Putnam County
      • Live Oak, Florida, United States, 32064
        • Suwannee County
      • Macclenny, Florida, United States, 32063
        • Baker County
      • Mayo, Florida, United States, 32066
        • Lafayette County
      • Starke, Florida, United States, 32091
        • Bradford County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: two years
two years
lipid profile
Time Frame: two years
two years
glycemic control
Time Frame: two years
two years
High-sensitivity C-reactive protein (hsCRP)
Time Frame: two years
two years
physical activity
Time Frame: two-years
two-years
physical performance
Time Frame: two-years
two-years
dietary intake
Time Frame: two-years
two-years
waist circumference
Time Frame: two-years
two-years
health-related quality of life
Time Frame: two-years
two-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael G. Perri, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RuralLITE-N
  • R18HL087800 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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