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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
Duke University Medical Center
Durham, North Carolina, United States
Executive Function composite
Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
Time frame: 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
Time frame: Baseline to immediate post-treatment (4 months)
Memory composite
CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
Time frame: Baseline to immediate post-treatment (4 months)
Brachial Artery Flow-Mediated Dilation
Time frame: Baseline to immediate post-treatment (4 months)
Prefrontal Cortex Tissue Oxygenation Index
Time frame: Baseline to immediate post-treatment (4 months)
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