MIND Foods and Aerobic Training in Black Adults With HTN
Recruiting · NCT06152614 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Fluent in English
- Marion County resident
- 35-75 years
- Self-identified non-Hispanic and Black/African-American/biracial including African-American
- Systolic BP of ≥140 in prior 12 months from a primary care visit
- Ability to see and read street signs (self report)
- Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)
- Activity independence per functional activities questionnaire (FAQ; \<3 responses of "Require Assistance" and 0 responses of "Dependent")
- Normal cognition per six-item screener (SIS; score of ≥ 5)
- Less than 20min on usual day of moderate or vigorous physical activity
- Able to exercise safely per abbreviated Exercise Assessment for You (EASY) or primary care provider clearance
- Mean systolic BP of ≥130 from 3 standard BP measurements taken by research staff following standardized wait periods.
Exclusion criteria
- lives in nursing home
- 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
- 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
- current or past prescription of donepezil, memantine, rivastigmine, or galantamine
- alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
- drug use/abuse (excluding marijuana) per EMR
- moving out of area during study timeline
- scheduling conflicts with intervention schedule
- unwilling to use a touchscreen
- unwilling to be on video conferencing
- low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
- unable to provide informed consent
- participation in any lifestyle modification/weight loss program (e.g., Weight Watchers, etc.)
Where it is running
1 location listed across 1 US state.
- Eskenazi Health - Indianapolis, Indiana, United States