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

• Published in: Contemporary clinical trials Vol. 141; p. 107533
• Main Authors: Sprague, Briana N., Tu, Wanzhu, Unverzagt, Frederick W., Moser, Lyndsi R., Adams, Mariah, Carter, Amy, Dawkins, Emily, Keith, NiCole R., Reinoso, Deanna R., Clark, Daniel O.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2024
• Subjects: Adult; Aerobic training; Aged; Black or African American; Blood Pressure; Cooking - methods; Exercise; Female; Humans; Hypertension - therapy; Hypertension self-management and support; Life Style; Lifestyle intervention; Male; Mediterranean diet; Middle Aged; Pilot Projects; Randomized controlled trial; Single-Blind Method; Hypertension self-management and support; Mediterranean diet; Randomized controlled trial; Aerobic training; Lifestyle intervention
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2024.107533

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. 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. 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.