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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IET and Nutrition | Experimental | 3 times per week of interval exercise training Once daily meal replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise & Dietary Supplement | Other |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Patients are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Family Medicine Center | Chapel Hill | North Carolina | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34337406 | Derived | Smith-Ryan AE, Weaver MA, Viera AJ, Weinberger M, Blue MNM, Hirsch KR. Promoting Exercise and Healthy Diet Among Primary Care Patients: Feasibility, Preliminary Outcomes, and Lessons Learned From a Pilot Trial With High Intensity Interval Exercise. Front Sports Act Living. 2021 Jul 16;3:690243. doi: 10.3389/fspor.2021.690243. eCollection 2021. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |