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

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.

The Indiana University telephone-based assessment of neuropsychological status: a new method for large scale neuropsychological assessment.

Sensitive measures of neuropsychological function were adapted to a telephone administration format for use in a large survey of quality of life in breast cancer survivors (BCS). Healthy controls (HC) and BCS were recruited from the community and administered the same neuropsychological test battery on two occasions separated by 1 week. Subjects were randomly assigned to conditions, stratified by diagnosis: In-person at Time-1 and In-person at Time-2 (P-P); Telephone at Time-1 and Telephone at Time-2 (T-T); T-P; and P-T. Four cognitive (Rey Auditory Verbal Learning Test, Controlled Oral Word Association, Digit Span, Symbol Digit) and two self-report measures (Squire Memory Self-Report Scale, Center for Epidemiological Studies Depression Scale) were used. The 106 subjects were randomized (54 HC and 52 BCS). Test-retest reliabilities (intraclass correlations) did not differ significantly by condition across the cognitive or self-report measures and ranged from moderate to near perfect (r's .43-.93; p's<.05). Mean scores at Time-1, practice effects (Time-1 to Time-2), and standard errors of measurement were comparable between In-person and Telephone administration formats. Results suggest that memory, attention, information processing speed, verbal fluency, and self-report of mood and memory can be measured reliably and precisely over the telephone.