Brain-Protecting diet and exercise trial launches for black adults with high blood pressure
NCT ID NCT06152614
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study looks at whether combining the MIND diet (a mix of Mediterranean and DASH diets) with aerobic exercise can help prevent memory and thinking problems in Black adults aged 35-75 who have high blood pressure. Participants will be randomly assigned to either receive food delivery, cooking lessons, and exercise training, or to continue their usual care. The study will track changes in cognitive function over 52 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eskenazi Health
RECRUITINGIndianapolis, Indiana, 46202, United States
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