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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: DASH diet Behavioral: DASH diet plus Weight loss||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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.
- 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 ]
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|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||James A. Blumenthal, Ph.D.||Duke University|