MIND Foods and Aerobic Training in Black Adults With HTN
MIND Foods and Aerobic Training in Black Adults With HTN: An ADRD Prevention Pilot RCT
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 35 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the MIND diet and aerobic exercise, which makes your heart beat faster, help thinking and memory in Black adults with high blood pressure. It compares food delivery, cooking, and exercise with enhanced usual care.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Are 35–75 years old, speak English fluently, and live in Marion County.
- Identify as non-Hispanic and Black, African American, or biracial including African American.
- Had a top blood pressure number of at least 140 at a primary care visit in the past 12 months. The average of 3 study readings must also be at least 130.
- Can see and read street signs.
- Have stable housing and your own access to a kitchen with a working stove or hotplate, oven, refrigerator, and freezer.
- Need help with fewer than 3 daily tasks and are not fully dependent on others for any task on the study checklist.
- Score at least 5 on a 6-item thinking and memory test.
- Usually do less than 20 minutes of moderate or hard physical activity a day, and can exercise safely based on a screening or your primary care provider’s approval.
Who can't join
- Live in a nursing home, plan to move away during the study, or have schedule conflicts with study sessions.
- Have dementia, Alzheimer’s disease, mild thinking or memory problems, or Parkinson’s disease; or had a brain tumor, infection, or surgery within the past 10 years with lasting symptoms or loss of ability.
- Have cancer with a short life expectancy, are getting chemotherapy or radiation, or have psychosis, schizophrenia, or bipolar disorder.
- Have certain coded blood pressure conditions: heart or kidney disease caused by high blood pressure, high blood pressure caused by another condition, or a blood pressure crisis.
- Have ever been prescribed donepezil, memantine, rivastigmine, or galantamine.
- Drink at least 8 alcoholic drinks a week if a woman, or at least 15 if a man; or have drug use or misuse, other than marijuana, in your medical record.
- Will not use a touchscreen or video calls; have communication problems, limits in daily tasks, or other conditions that staff think would prevent participation; or cannot give informed consent.
- Are taking part in a lifestyle-change or weight-loss program.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.)
Study sites (1)
IN
- Eskenazi Health · Indianapolis, IN 46202More trials in Indianapolis