Status:
RECRUITING
MIND Foods and Aerobic Training in Black Adults With HTN
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Cognitive Decline
Hypertension
Eligibility:
All Genders
35-75 years
Phase:
NA
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 wit...
Detailed Description
This randomized controlled trial will evaluate Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training (FoRKS+) versus enhanced usual care (EUC) in Black adults wi...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06152614
Start Date
November 28 2023
End Date
January 30 2028
Last Update
February 7 2025
Active Locations (1)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202