RECRUITING

MIND Foods and Aerobic Training in Black Adults With HTN

Conditions

Cognitive Decline Hypertension Diet Aerobic Exercise nutrition cooking exercise

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-28

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06152614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 ≥130 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings)	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.)

Inclusion Criteria

Exclusion 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 ≥130 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings)

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.)

Contacts and Locations

Study Contact

Daniel O Clark, PhD

CONTACT

317-274-9292

daniclar@iu.edu

Lyndsi R Moser, BA, CCRP

CONTACT

317-963-7301

lrhabegg@iupui.edu

Principal Investigator

Daniel O Clark, PhD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Eskenazi Health

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Daniel O Clark, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-11-28

Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

nutrition
cooking
exercise
hypertension

Additional Relevant MeSH Terms

Cognitive Decline
Hypertension
Diet
Aerobic Exercise