Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06152614

MIND Foods and Aerobic Training in Black Adults With HTN

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

About this study

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 pass the telephone screen will be invited to complete a blood pressure check for final eligibility determination. Participants must receive an average systolic read of ≥130 mmHG across 3 standard BP readings with designated wait periods; a maximum of 5 readings may be attempted to receive 3 successful measurements necessary to calculate the average. Participants who meet criteria and give informed consent will complete a full baseline assessment, consisting of cognitive and cardiovascular assessments, blood pressure, weight, HbA1c testing, questionnaires, 24-hour ambulatory blood pressure 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent in English
  • Marion County resident
  • 35-75 years
  • Self-identified non-Hispanic and Black/African-American/biracial including African-American
  • Systolic BP of ≥140 in prior 12 months from a primary care visit
  • Ability to see and read street signs (self report)
  • Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)
  • Activity independence per functional activities questionnaire (FAQ; <3 responses of "Require Assistance" and 0 responses of "Dependent")
  • Normal cognition per six-item screener (SIS; score of ≥ 5)
  • Less than 20min on usual day of moderate or vigorous physical activity
  • Able to exercise safely per abbreviated Exercise Assessment for You (EASY) or primary care provider clearance
  • Mean systolic BP of ≥130 from 3 standard BP measurements taken by research staff following standardized wait periods.

Exclusion criteria

  • lives in nursing home
  • diagnosis of dementia or Alzheimer disease or mild cognitive impairment; Parkinson disease; brain tumor/infection/surgery (within the last 10 years with residual symptoms and/or functional loss/deficit, such as impaired learning, memory, or communication); cancer with short life expectancy, or current chemotherapy or radiation therapy; psychosis, schizophrenia, or bipolar disorder
  • ICD 10 code I11/hypertensive heart disease, ICD 10 code I12/hypertensive CKD, ICD 10 code I13/hypertensive heart disease and CKD, ICD 10 code I15, or ICD 10 code I16
  • current or past prescription of donepezil, memantine, rivastigmine, or galantamine
  • alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
  • drug use/abuse (excluding marijuana) per EMR
  • moving out of area during study timeline
  • scheduling conflicts with intervention schedule
  • unwilling to use a touchscreen
  • unwilling to be on video conferencing
  • low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
  • unable to provide informed consent
  • participation in any lifestyle modification/weight loss program (e.g., Weight Watchers, etc.)

Treatment and study plan

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.

Primary outcomes

  1. 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

    The cognitive composite is derived from WAIS-IV Symbol Search & Coding, Trail Making Test Part B, Animals-Vegetables-Clothing Naming, Stroop Color-Word, and RBANS Update List Learning and List Recall. The composite will be formed by standardizing each test raw score to the sample baseline mean and standard deviation and then taking an average of the resultant z-scores. These measures will be combined into a single, overall cognitive composite score.

  2. 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 52.

    Time frame: Week 52 post intervention start date

    The cognitive composite is derived from WAIS-IV Symbol Search & Coding, Trail Making Test Part B, Animals-Vegetables-Clothing Naming, Stroop Color-Word, and RBANS Update List Learning and List Recall. The composite will be formed by standardizing each test raw score to the sample baseline mean and standard deviation and then taking an average of the resultant z-scores. These measures will be combined into a single, overall cognitive composite score.

Secondary outcomes

  1. Average participant self-ratings of intervention acceptability.

    Time frame: From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.

    Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) throughout the 28-week intervention.

  2. Participant adherence to treatment.

    Time frame: From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.

    Number of training sessions attended divided by the the total number of sessions available.

  3. Participant adherence to outcome assessments.

    Time frame: End of follow-up at 52-weeks.

    Number of participants completing the outcome assessments divided by the total number randomized.

  4. Number of participants with study-related adverse events (AE) by treatment arm.

    Time frame: From enrollment through end of follow-up at 52-weeks.

    Adverse event count for each study arm

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel O Clark, PhD

CONTACT

[email protected]

317-274-9292

Lyndsi R Moser, BA, CCRP

CONTACT

[email protected]

317-278-7727

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

MIND Foods and Aerobic Training in Black Adults With HTN: An ADRD Prevention Pilot RCT

Acronym: MAT

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 30, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.