Rural Lifestyle Eating and Activity Program (Rural LEAP)

Completed · Not applicable

Conditions studied: Obesity

In brief

The purpose of this research study is to learn about ways to help adults with obesity from rural areas manage their weight and increase their physical activity. An important goal of the study is to find out what type of follow-up program for weight management is necessary to help adults with obesity keep from regaining lost weight. The study will also look at the ways that long-term weight-loss treatments affect blood pressure, blood fats (lipids), blood sugar, and physical fitness. The participant are being asked to be in this research study because increased weight and obesity are major health problems in the United States. The participant's weight and height fall in the obese category. Adults with obesity have an increased risk of developing health problems such as high blood pressure, diabetes, and heart disease. The rates of being overweight and obese are higher in rural areas of the United States than in urban and suburban areas of the country.

Key facts

Study ID

NCT02054624

Run by

University of Florida

People needed

631

Starts

2013-08-01

Expected to finish

2020-04-01

Last updated by the study team

2021-09-14

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 21 to 75 years
• Body Mass Index: 30 to 45 kg/m**2

You may not qualify if…

• 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 (patients with diabetes under active treatment will be enrolled if approved by primary provider); fasting serum triglycerides > 400 mg/dl at screening; resting blood pressure > 150/100 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

Where it is running

• Levy County — Bronson, Florida, United States
• Flagler County — Bunnell, Florida, United States
• Dixie County — Cross City, Florida, United States
• Hamilton County — Jasper, Florida, United States
• Union County — Lake Butler, Florida, United States
• Columbia County — Lake City, Florida, United States
• Suwannee County — Live Oak, Florida, United States
• Baker County — Macclenny, Florida, United States
• Madison County — Madison, Florida, United States
• Lafayette County — Mayo, Florida, United States
• Putnam County — Palatka, Florida, United States
• Taylor County — Perry, Florida, United States
• Bradford County — Starke, Florida, United States
• Gilchrist County — Trenton, Florida, United States

Full record on ClinicalTrials.gov

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