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ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00571844
First received: December 10, 2007
Last updated: July 11, 2014
Last verified: November 2013

December 10, 2007
July 11, 2014
October 2003
July 2009   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00571844 on ClinicalTrials.gov Archive Site
Ambulatory blood pressure,vascular function,left ventricular geometry, glucose tolerance,body composition, quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health
Behavioral Treatment of High Blood Pressure

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Behavioral: DASH diet
    Participants in the DASH diet condition receive instruction in modifying the content of their diet to meet DASH guidelines. Participants are explicitly asked not to exercise or to attempt weight loss at this time, and to focus their attention on what they eat. Following the 2-week feeding period, participants will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 5 participants).
  • Behavioral: DASH diet plus Weight loss
    Participants in the DASH diet plus weight loss condition will receive the DASH dietary intervention as described in the DASH diet intervention and will participate in a program to promote weight loss consisting of 2 components: Supervised Aerobic Exercise and CBWL (Cognitive Behavioral Weight loss). During supervised exercise participants will exercise 3x/week under medical supervision at the Duke Center for Living. A trained exercise physiologist will supervise all exercise sessions, and will obtain exercise BP measurements to make sure that BP is not abnormally elevated. For the CBWL participants will meet in small groups of 3-5 patients for instruction in weight management techniques. CBWL will include Appetite Awareness Training (AAT), a self-monitoring strategy developed to provide more specific guidelines regarding how much to eat. Individuals learn to identify moderate hunger and fullness and use these internal cues to guide their eating.
  • Experimental: DASH diet
    Intervention: Behavioral: DASH diet
  • Experimental: DASH diet plus Weight loss
    Intervention: Behavioral: DASH diet plus Weight loss
  • No Intervention: Usual Care
    Usual Care Control Group: Patients in the Usual Care control group will be asked to maintain their usual dietary and exercise habits for 4 months until they are re-evaluated. At biweekly intervals we will ask patients to describe any spontaneous changes in their eating habits or food preferences. To ensure patient safety, BPs will also be monitored biweekly by our staff.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
July 2013
July 2009   (final data collection date for primary outcome measure)

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
Both
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571844
Pro00007858, 5 R01 HL074103, 4842
Yes
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James A. Blumenthal, Ph.D. Duke University
Duke University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP