Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/15/2017 |
| Start Date: | May 2015 |
| End Date: | January 2017 |
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.
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.
Inclusion Criteria:
Patients are:
1. > 18-85 years;
2. receive primary care in the FMC (> 1 visit during the previous year); and
3. have ≥1 risk factor or developing risk factors for CVD (blood pressure >130/85 mmHG,
BMI >25 kg/m2(or ~20 lbs overweight), Fasting glucose >110 mg/dl, OR 4) HDL <30) (all
identified via medical record)
Exclusion Criteria:
1. those for whom exercise and/or diet are contraindicated (e.g., scheduled for
arthroplasty) or who are at risk of death in the next year (e.g., Class IV heart
failure, end-stage renal disease).
2. those taking medication for diabetes, blood pressure, and lipids for more than 2
years.
3. pregnant or planning on becoming pregnant within the next year.
4. Allergic to any ingredient in the nutritional meal replacement.
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