Impact of MIND Diet and Aerobic Training on Cognition in Black Adults with High Blood Pressure

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

This study is testing if following a special diet and doing aerobic exercise can help improve thinking skills and health in Black adults with high blood pressure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Indiana University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT06152614 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to assess the effects of the Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet combined with aerobic training on cognitive function in Black adults with high systolic blood pressure. Participants will be divided into two groups: one receiving enhanced usual care and the other receiving food delivery, cooking training, and aerobic exercise. The study will include various assessments such as cognitive tests, blood pressure monitoring, and optional DNA testing to evaluate the impact of diet and exercise on cognition and cardiovascular health. The goal is to determine if these interventions can reduce cognitive decline and improve health outcomes in this population.

Who should consider this trial

Good fit: Ideal candidates are Black adults aged 35-75 with a history of high systolic blood pressure.

Not a fit: Patients living in nursing homes or those unable to exercise safely may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive health and better management of hypertension in Black adults.

How similar studies have performed: Other studies have shown promising results with dietary and exercise interventions for cognitive health, suggesting this approach may be effective.

Eligibility criteria

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.)

Where this trial is running

Indianapolis, Indiana

• Eskenazi Health — Indianapolis, Indiana, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel O Clark, PhD — Indiana University
• Study coordinator: Daniel O Clark, PhD

Conditions: Cognitive Decline, Hypertension, Diet, Aerobic Exercise, nutrition, cooking, exercise, hypertension