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This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control BP in individuals with RH. In the parent trial, participants with RH will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control condition.
The current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured center-based lifestyle intervention | Experimental | The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise. |
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| Standard education and physician advice | Experimental | The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured center-based lifestyle intervention | Behavioral |
| ||
| Standard education and physician advice |
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function composite | Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index | Baseline to immediate post-treatment (4 months) |
| Processing Speed composite | Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test | Baseline to immediate post-treatment (4 months) |
| Memory composite | CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa | Baseline to immediate post-treatment (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Flow-Mediated Dilation | Baseline to immediate post-treatment (4 months) | |
| Prefrontal Cortex Tissue Oxygenation Index | Baseline to immediate post-treatment (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function composite | Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index | Baseline to follow-up (1 year) |
| Processing Speed composite | Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26542509 | Background | Blumenthal JA, Sherwood A, Smith PJ, Mabe S, Watkins L, Lin PH, Craighead LW, Babyak M, Tyson C, Young K, Ashworth M, Kraus W, Liao L, Hinderliter A. Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial. Am Heart J. 2015 Nov;170(5):986-994.e5. doi: 10.1016/j.ahj.2015.08.006. Epub 2015 Aug 14. |
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| Behavioral |
|
| Baseline to follow-up (1 year) |
| Memory composite | CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa | Baseline to follow-up (1 year) |