Rural Lifestyle Intervention Treatment Effectiveness Trial
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Intervention name(s): lifestyle intervention; Health Education Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three doses of lifestyle intervention will be compared to an education control condition.; Health education control group will receive 16 session of health education related to diet and exercise over a two-year period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; rural health; exercise