MIND Foods and Aerobic Training in Black Adults With HTN

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06152614
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Usual Care (EUC) — BEHAVIORAL
    Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.
  • Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) — BEHAVIORAL
    Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) includes 5 weeks of hypertension classes followed by 11 weeks of home-delivered Mediterranean-style ingredient kits and virtual cooking classes, and an additional 12 weeks of aerobic exercise.

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Enhanced Usual Care (EUC)
    Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.
  • Experimental: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)
    Participants randomized to FoRKS+ will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS+ intervention. Following HTN SMES completion, FoRKS+ continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16. Intervention continues with aerobic exercise led by health coaches via Webex. Classes start in Week 13 with one session per week, increasing to two sessions per week in Weeks 17-28.

Primary Outcome Measure

Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, semantic fluency, interference and list learning and delayed recall at Week 28. [ Time Frame: Week 28 post intervention start date ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eskenazi HealthIndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Eskenazi Health· Indianapolis, IN

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