Clinical trial NCT06152614: MIND Foods and Aerobic Training in Black Adults With HTN
Official title: MIND Foods and Aerobic Training in Black Adults With HTN: An ADRD Prevention Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Hypertension
Diet
Aerobic Exercise
Keywords: nutrition
cooking
exercise
hypertension
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2023-11-30
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 with systolic blood pressure of ≥140 mm Hg. This project seeks to evaluate the potential for high-polyphenol nutritious foods, hands-on training in food management skills, and aerobic exercise to impact cognition and risk factor reduction in persons with prevalent chronic disease.

Adults who pass the telephone screen will be invited to complete a blood pressure check for final eligibility determination. Participants must receive an average systolic read of ≥130 mmHG across 3 standard BP readings with designated wait periods; a maximum of 5 readings may be attempted to receive 3 successful measurements necessary to calculate the average. 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.

Participants will be randomized to one of two arms:

Enhanced Usual Care (EUC), consisting of access to existing usual primary care services such as social determinants of health screenings, referrals to food pantries, and assistance enrolling in food assistance programs. They will be enrolled in a 5-week Hypertension Self-Management Education and Support (SMES) class, which is an existing CDC-endorsed program offered at Eskenazi to provide information and skills for managing hypertension (HTN).

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+), consisting of the same services as EUC plus home-delivered MIND diet ingredient kits and virtual cooking classes for an additional 11 weeks with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping; PLUS aerobic training for an additional 12 weeks of moderate-intensity exercise.

Assessments will be completed at mid-intervention around Week 16, Week 28 as the primary endpoint, and around Week 52 for maintenance evaluation.

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.)

Primary outcomes:
measure: Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, semantic fluency, interference and list learning and delayed recall at Week 28.
timeFrame: Week 28 post intervention start date
measure: Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, semantic fluency, interference and list learning and delayed recall at Week 52.
timeFrame: Week 52 post intervention start date
Secondary outcomes:
measure: Average participant self-ratings of intervention acceptability.
timeFrame: From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.
measure: Participant adherence to treatment.
timeFrame: From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.
measure: Participant adherence to outcome assessments.
timeFrame: End of follow-up at 52-weeks.
measure: Number of participants with study-related adverse events (AE) by treatment arm.
timeFrame: From enrollment through end of follow-up at 52-weeks.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Daniel O Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References: