MIND Foods and Aerobic Training in Black Adults With HTN

Last updated: February 6, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Memory Problems

Memory Loss

Treatment

Enhanced Usual Care (EUC)

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

Clinical Study ID

NCT06152614
16547
R01AG076685
  • Ages 35-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fluent in English

  2. Marion County resident

  3. 35-75 years

  4. Self-identified non-Hispanic and Black/African-American/biracial includingAfrican-American

  5. Systolic BP of ≥140 in prior 12 months from a primary care visit

  6. Ability to see and read street signs (self report)

  7. Stable housing with independent access to kitchen, including functional stove orhotplate, oven, refrigerator, and freezer (self report)

  8. Activity independence per functional activities questionnaire (FAQ; <3 responses of "Require Assistance" and 0 responses of "Dependent")

  9. Normal cognition per six-item screener (SIS; score of ≥ 5)

  10. Less than 20min on usual day of moderate or vigorous physical activity

  11. Able to exercise safely per abbreviated Exercise Assessment for You (EASY) orprimary care provider clearance

  12. Mean systolic BP of ≥130 from 3 standard BP measurements taken by research stafffollowing standardized wait periods.

Exclusion

Exclusion Criteria:

  1. lives in nursing home

  2. diagnosis of dementia or Alzheimer disease or mild cognitive impairment; Parkinsondisease; brain tumor/infection/surgery (within the last 10 years with residualsymptoms and/or functional loss/deficit, such as impaired learning, memory, orcommunication); cancer with short life expectancy, or current chemotherapy orradiation therapy; psychosis, schizophrenia, or bipolar disorder

  3. ICD 10 code I11/hypertensive heart disease, ICD 10 code I12/hypertensive CKD, ICD 10code I13/hypertensive heart disease and CKD, ICD 10 code I15, or ICD 10 code I16

  4. current or past prescription of donepezil, memantine, rivastigmine, or galantamine

  5. alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men

  6. drug use/abuse (excluding marijuana) per EMR

  7. moving out of area during study timeline

  8. scheduling conflicts with intervention schedule

  9. unwilling to use a touchscreen

  10. unwilling to be on video conferencing

  11. low communicative ability, functional status, or other disorders (examiner rated)that would interfere with interventions and assessments

  12. unable to provide informed consent

  13. participation in any lifestyle modification/weight loss program (e.g., WeightWatchers, etc.)

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Enhanced Usual Care (EUC)
Phase:
Study Start date:
November 28, 2023
Estimated Completion Date:
January 30, 2028

Study Description

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.

Connect with a study center

  • Eskenazi Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.