ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health (ENCORE)
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ClinicalTrials.gov Identifier: NCT00571844 |
Recruitment Status :
Completed
First Posted : December 12, 2007
Last Update Posted : July 14, 2014
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: DASH diet Behavioral: DASH diet plus Weight loss | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Behavioral Treatment of High Blood Pressure |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
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Experimental: DASH diet |
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). |
Experimental: DASH diet plus Weight loss |
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. |
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.
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- Blood pressure [ Time Frame: 4 months ]
- Ambulatory blood pressure,vascular function,left ventricular geometry, glucose tolerance,body composition, quality of life [ Time Frame: 4 months ]

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Baseline SBP 130-159 mmHg (+/- 2mmHg) or DBP 85-99 mmHg (+/- 2 mm Hg)
- Age 35 years or older
- BMI 25.0-39.99 kg/m², with a maximum weight of 300 lbs
- Willing and able to participate fully in all aspects of the intervention
- Must currently be sedentary (less than 3x/wk for 30 mins each time)
- Informed consent
Exclusion Criteria:
- Use of weight-loss medication and/or participation in a structured weight- loss program in the 3 months prior to 1st screening visit.
- 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
- Current use of insulin or oral hypoglycemic agents
- Current use of medications for treatment of psychosis or manic-depressive illness.
- ADHD medications (Ritalin/Aderol/amphetamines
- Cardiovascular Event
- Coronary Artery Disease
- Congestive Heart Failure
- Current symptoms of Angina for peripheral vascular disease
- Cancer diagnosis (except for non-melanoma skin cancer) or treatment in past 2 years
- Fasting blood sugar >126 mg/dl
- Gastric Bypass/Bariatric Surgery
- Pyschiatric hospitalization in the past 2 years.
- Unable or willing to consume all of the dietary foods provided during the 2-week feeding.
- Consumption of more than 21 alcoholic drinks per week or binge drinking
- Alcoholism as determined by the Alcohol AUDIT (screening questionnaires)
- Planning to leave the area prior to the anticipated end of participation
- Body weight change of >15lbs in the 3 months prior to the 1st screening visit
- Pregnant, breast feeding, or planning pregnancy prior to end of participation
- Current participation in another clinical trial until after completion of T2
- Investigator discretion for safety or adherence reasons
- Controlled substance abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571844
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | James A. Blumenthal, Ph.D. | Duke University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00571844 History of Changes |
Other Study ID Numbers: |
Pro00007858 5R01HL074103 ( U.S. NIH Grant/Contract ) 4842 ( Other Identifier: Duke legacy protocol number ) |
First Posted: | December 12, 2007 Key Record Dates |
Last Update Posted: | July 14, 2014 |
Last Verified: | November 2013 |
High Blood Pressure Exercise Diet Biomarkers |
Hypertension Vascular Diseases Cardiovascular Diseases |