ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health
ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health
This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the
 effects of the DASH diet alone and combined with a behavioral weight loss program on blood
 pressure and various vascular measures. Eligible patients must be unmedicated with blood
 pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as
 follows: (1) The DASH diet alone and combined with a behavioral weight management program
 will result in greater BP reductions than Usual Care controls at the end of the 4 month
 treatment period; (2) The DASH diet in combination with a behavioral weight management
 program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet
 alone and the DASH diet combined with the behavioral weight management program will result in
 greater improvements in cardiac, metabolic, and vascular function compared to the control
 condition; and (4) The combined DASH diet and weight management intervention also will be the
 most effective treatment in maintaining BP reductions at 1-year follow-up.
The present application seeks to extend previous findings by a) evaluating the efficacy of
 the DASH diet in a free-living situation; (b) considering the DASH diet alone and in
 combination with a behavioral weight loss program including aerobic exercise; (c) examining
 the impact of diet and exercise on cardiac, metabolic, and vascular function, including
 measures of arterial stiffness, endothelial function, baroreflex control, body composition,
 insulin resistance, cardiac hemodynamics, and left ventricular (LV) geometry and mass; and
 (d) following patients for one year to determine the longer term impact of the interventions
 on BP, body weight, and cardiovascular function.
Inclusion Criteria:

 1. Baseline SBP 130-159 mmHg (+/- 2mmHg) or DBP 85-99 mmHg (+/- 2 mm Hg)

 2. Age 35 years or older

 3. BMI 25.0-39.99 kg/m², with a maximum weight of 300 lbs

 4. Willing and able to participate fully in all aspects of the intervention

 5. Must currently be sedentary (less than 3x/wk for 30 mins each time)

 6. Informed consent

 Exclusion Criteria:

 1. Use of weight-loss medication and/or participation in a structured weight- loss
 program in the 3 months prior to 1st screening visit.

 2. Regular use of an anti-hypertensive drug or other drugs that raise or lower BP and if
 discontinued use, must be off for 1 month before screening

 3. Current use of insulin or oral hypoglycemic agents

 4. Current use of medications for treatment of psychosis or manic-depressive illness.

 5. ADHD medications (Ritalin/Aderol/amphetamines

 6. Cardiovascular Event

 7. Coronary Artery Disease

 8. Congestive Heart Failure

 9. Current symptoms of Angina for peripheral vascular disease

 10. Cancer diagnosis (except for non-melanoma skin cancer) or treatment in past 2 years

 11. Fasting blood sugar >126 mg/dl

 12. Gastric Bypass/Bariatric Surgery

 13. Pyschiatric hospitalization in the past 2 years.

 14. Unable or willing to consume all of the dietary foods provided during the 2-week
 feeding.

 15. Consumption of more than 21 alcoholic drinks per week or binge drinking

 16. Alcoholism as determined by the Alcohol AUDIT (screening questionnaires)

 17. Planning to leave the area prior to the anticipated end of participation

 18. Body weight change of >15lbs in the 3 months prior to the 1st screening visit

 19. Pregnant, breast feeding, or planning pregnancy prior to end of participation

 20. Current participation in another clinical trial until after completion of T2

 21. Investigator discretion for safety or adherence reasons

 22. Controlled substance abuse