Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk

Conditions
-----------------
Pre-Diabetic, Overweight, Obesity

Intervention / Treatment
-----------------
* Other: Exercise & Dietary Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are: > 18-85 years; receive primary care in the FMC (> 1 visit during the previous year); and 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: 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). those taking medication for diabetes, blood pressure, and lipids for more than 2 years. pregnant or planning on becoming pregnant within the next year. Allergic to any ingredient in the nutritional meal replacement.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IET and Nutrition<br>3 times per week of interval exercise training Once daily meal replacement | Other: Exercise & Dietary Supplement<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that complete exercise program |  | 3 months | 
| Number of participants that complete nutrition program |  | 3 months | 
| Number of exercise sessions completed |  | 3 months | 
| Number of days nutrition program followed |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months |  | 3 months, 6 months, 12 months | 
| Change in fat mass at 3 months, 6 months, and 12 months |  | 3 months, 6 months, 12 months | 
| Change in lean mass at 3 months, 6 months, and 12 months |  | 3 months, 6 months, 12 months | 
| Change in blood lipids at 3 months, 6 months, 12 months |  | 3 months, 6 months, 12 months | 
| Change in hemoglobin A1c at 3 months, 6 months, 12 months |  | 3 months, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
feasibility studies, intervention, Pre-Hypertensive, Pre-Hyperlipidemia