Recruiting

MIND Foods & Aerobic Training

Sponsor:

Indiana University

Code:

NCT06152614

Conditions

Cognitive Decline

Hypertension

Diet

Aerobic Exercise

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Enhanced Usual Care (EUC)

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

Study Details

Brief 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.

Conditions

Cognitive Decline

Hypertension

Diet

Aerobic Exercise

Study ID

NCT06152614

Start date

Nov 28, 2023

Status verified date

Jul, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Fluent in English
2. Marion County resident
3. 35-75 years
4. Self-identified non-Hispanic and Black/African-American/biracial including African-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 or hotplate, 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) or primary care provider clearance
12. Mean systolic BP of ≥130 from 3 standard BP measurements taken by research staff following standardized wait periods.

Exclusion Criteria:

1. lives in nursing home
2. 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
3. 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
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., Weight Watchers, etc.)

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

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 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Daniel O Clark, PhD

317-274-9292daniclar@iu.edu

Lyndsi R Moser, BA, CCRP

317-278-7727lrhabegg@iu.edu

Locations

Eskenazi Health

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • nutrition
  • cooking
  • exercise
  • hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-22.