Obesity Clinical Trial
Official title:
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk
Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise
training (IET) and nutrition program, as well as its preliminary effects on resting heart
rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among
primary care patients who have at least one risk factor for cardiovascular disease (CVD).
Participants : 30 patients who receive care from the University of North Carolina (UNC)
Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC
patients, not diagnosed with severe illness), will be enrolled to test the feasibility of
the home-based interval exercise and nutrition program.
Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In
Phase I, 15 patients will be enrolled into the program, which will take approximately 3
months. At baseline, data will be collected on age, height, weight, resting heart rate,
blood pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin,
percent body fat, cardiovascular fitness, and use a series of questionnaires to evaluate
mood, sleep, hunger, and quality of life. At closeout, the investigators will measure
patients' adherence to each component of the intervention. In Phase II, an additional 15 new
patients will be enrolled in either the identical protocol, or a slightly modified
intervention (if necessary based upon our results from Phase I). All patients will have the
same variables measured at baseline during their study visit at 3, 6 and 12 months after
enrollment into the study.
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