Clinical trial NCT00912652: Rural Lifestyle Intervention Treatment Effectiveness Trial
Official title: Rural Lifestyle Intervention Treatment Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
rural health
exercise
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-06-03
Enrollment: 612
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: body weight
timeFrame: two years
Secondary outcomes:
measure: blood pressure
timeFrame: two years
measure: lipid profile
timeFrame: two years
measure: glycemic control
timeFrame: two years
measure: High-sensitivity C-reactive protein (hsCRP)
timeFrame: two years
measure: physical activity
timeFrame: two-years
measure: physical performance
timeFrame: two-years
measure: dietary intake
timeFrame: two-years
measure: waist circumference
timeFrame: two-years
measure: health-related quality of life
timeFrame: two-years
Other outcomes:
Locations:
city: Bronson
country: United States
facility: Levy County
state: Florida
city: Bunnell
country: United States
facility: Flagler County
state: Florida
city: Cross City
country: United States
facility: Dixie County
state: Florida
city: East Palatka
country: United States
facility: Putnam County
state: Florida
city: Live Oak
country: United States
facility: Suwannee County
state: Florida
city: Macclenny
country: United States
facility: Baker County
state: Florida
city: Mayo
country: United States
facility: Lafayette County
state: Florida
city: Starke
country: United States
facility: Bradford County
state: Florida
Study officials:
affiliation: University of Florida
name: Michael G. Perri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perri MG, Limacher MC, von Castel-Roberts K, Daniels MJ, Durning PE, Janicke DM, Bobroff LB, Radcliff TA, Milsom VA, Kim C, Martin AD. Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial. Obesity (Silver Spring). 2014 Nov;22(11):2293-300. doi: 10.1002/oby.20832.
citation: Radcliff TA, Cote MJ, Whittington MD, Daniels MJ, Bobroff LB, Janicke DM, Perri MG. Cost-Effectiveness of Three Doses of a Behavioral Intervention to Prevent or Delay Type 2 Diabetes in Rural Areas. J Acad Nutr Diet. 2020 Jul;120(7):1163-1171. doi: 10.1016/j.jand.2019.10.025. Epub 2019 Dec 30.
citation: Bauman V, Ariel-Donges AH, Gordon EL, Daniels MJ, Xu D, Ross KM, Limacher MC, Perri MG. Effect of dose of behavioral weight loss treatment on glycemic control in adults with prediabetes. BMJ Open Diabetes Res Care. 2019 May 28;7(1):e000653. doi: 10.1136/bmjdrc-2019-000653. eCollection 2019.