Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol.

Autor: Sprague BN; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA. Electronic address: bspragu@iu.edu., Tu W; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA., Unverzagt FW; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA., Moser LR; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA., Adams M; Department of Kinesiology, Indiana University Bloomington, Bloomington, IN, USA., Carter A; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA., Dawkins E; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA., Keith NR; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Department of Kinesiology, Indiana University Bloomington, Bloomington, IN, USA., Reinoso DR; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA., Clark DO; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Jun; Vol. 141, pp. 107533. Date of Electronic Publication: 2024 Apr 15.
DOI: 10.1016/j.cct.2024.107533
Abstrakt: Background: Midlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults.
Methods and Study Design: The Food Resources and Kitchen Skills plus Aerobic Training (FoRKS+) study is a 2-arm, single-blinded trial that compares those receiving the FoRKS+ program (target N = 64) versus those receiving enhanced usual care (target N = 64) in local federally-qualified health centers. Key eligibility criteria include self-identified NHB adults between ages 35-75 with a mean systolic blood pressure ≥ 130 mm/Hg obtained from 24-h ambulatory blood pressure monitoring. The FoRKS+ program includes 5 weeks of hypertension self-management courses, 11 weeks of nutrition courses, and 12 weeks of aerobic training in dietitian and health coach-led virtual groups. We will collect data on primary cognitive outcomes, feasibility, hypothesized intervention mediators and moderators, and demographic and health covariates at baseline, near intervention weeks 16-, and 28 (primary outcome assessment), and week 52 follow-up. We will use mixed-effects modeling to examine intervention effects on cognition.
Discussion: This pilot RCT will examine the feasibility and preliminary effects of a multicomponent lifestyle intervention on cognitive function in NHB adults, which may have implications for reducing health disparities in ADRD.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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