MIND Foods and Aerobic Training in Black Adults With HTN

Hypertension Clinical Trial

— MAT  

Official title:

MIND Foods and Aerobic Training in Black Adults With HTN: An ADRD Prevention Pilot RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152614
• Other study ID #: 16547
• Secondary ID: R01AG076685
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: December 2023
• Source: Indiana University
• Contact: Daniel O Clark, PhD
• Phone: 317-274-9292
• Email: daniclar[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 give informed consent will complete a 24-hour ambulatory blood pressure measure to confirm blood pressure eligibility. Participants who meet criteria will complete a full baseline assessment, consisting of cognitive and cardiovascular assessments, blood pressure, weight, HbA1c testing, questionnaires, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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. At Eligibility Visit: Mean systolic BP of =140 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings)

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.)

Related Conditions & MeSH terms

• Aerobic Exercise
• Cognitive Decline
• Cognitive Dysfunction
• Diet
• Hypertension

Intervention

Behavioral:
• Enhanced Usual Care (EUC)
Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.
• Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)
Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) includes 5 weeks of hypertension classes followed by 11 weeks of home-delivered Mediterranean-style ingredient kits and virtual cooking classes, and an additional 12 weeks of aerobic exercise.

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The cognitive composite is derived from WAIS-IV Symbol Search & Coding, Trail Making Test Part B, Animals-Vegetables-Clothing Naming, Stroop Color-Word, and RBANS Update List Learning and List Recall. The composite will be formed by standardizing each test raw score to the sample baseline mean and standard deviation and then taking an average of the resultant z-scores. These measures will be combined into a single, overall cognitive composite score.	Week 28 post intervention start date
Primary	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.	The cognitive composite is derived from WAIS-IV Symbol Search & Coding, Trail Making Test Part B, Animals-Vegetables-Clothing Naming, Stroop Color-Word, and RBANS Update List Learning and List Recall. The composite will be formed by standardizing each test raw score to the sample baseline mean and standard deviation and then taking an average of the resultant z-scores. These measures will be combined into a single, overall cognitive composite score.	Week 52 post intervention start date
Secondary	Average participant self-ratings of intervention acceptability.	Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) throughout the 28-week intervention.	From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.
Secondary	Participant adherence to treatment.	Number of training sessions attended divided by the the total number of sessions available.	From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.
Secondary	Participant adherence to outcome assessments.	Number of participants completing the outcome assessments divided by the total number randomized.	End of follow-up at 52-weeks.
Secondary	Number of participants with study-related adverse events (AE) by treatment arm.	Adverse event count for each study arm	From enrollment through end of follow-up at 52-weeks.