Hypertension Clinical Trial
Official title:
MIND Foods and Aerobic Training in Black Adults With HTN: An ADRD Prevention Pilot RCT
The goal of this randomized controlled trial is to determine the impact of Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training on cognition in Black adults with high systolic blood pressure. Researchers will compare Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) versus Enhanced Usual Care (EUC) to evaluate the effects on cognition. Participants will complete cognitive and cardiovascular assessments, 24-hr blood pressure monitoring, standard blood pressure measurements, weight, fingerstick for HbA1c point-of-care testing, and questionnaires. Participants may also choose to participate in an optional blood draw for DNA Repair Capacity testing as a modifiable risk factor for aging-associated diseases.
This randomized controlled trial will evaluate Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training (FoRKS+) versus enhanced usual care (EUC) in Black adults with systolic blood pressure of ≥140 mm Hg. This project seeks to evaluate the potential for high-polyphenol nutritious foods, hands-on training in food management skills, and aerobic exercise to impact cognition and risk factor reduction in persons with prevalent chronic disease. Adults who give informed consent will complete a 24-hour ambulatory blood pressure measure to confirm blood pressure eligibility. Participants who meet criteria will complete a full baseline assessment, consisting of cognitive and cardiovascular assessments, blood pressure, weight, HbA1c testing, questionnaires, and optional blood draw. Participants will be randomized to one of two arms: Enhanced Usual Care (EUC), consisting of access to existing usual primary care services such as social determinants of health screenings, referrals to food pantries, and assistance enrolling in food assistance programs. They will be enrolled in a 5-week Hypertension Self-Management Education and Support (SMES) class, which is an existing CDC-endorsed program offered at Eskenazi to provide information and skills for managing hypertension (HTN). Food Delivery and Cooking PLUS Aerobic Training (FoRKS+), consisting of the same services as EUC plus home-delivered MIND diet ingredient kits and virtual cooking classes for an additional 11 weeks with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping; PLUS aerobic training for an additional 12 weeks of moderate-intensity exercise. Assessments will be completed at mid-intervention around Week 16, Week 28 as the primary endpoint, and around Week 52 for maintenance evaluation. ;
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