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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Indiana
Eskenazi Health
RECRUITING
Indianapolis
Contact Information
Primary
Daniel O Clark, PhD
daniclar@iu.edu
317-274-9292
Backup
Lyndsi R Moser, BA, CCRP
lrhabegg@iupui.edu
317-963-7301
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 128
Treatments
Active_comparator: Enhanced Usual Care (EUC)
Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class (Hypertension group), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.
Experimental: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)
Participants randomized to FoRKS+ will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS+ intervention.~Following HTN SMES completion, FoRKS+ continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16. Intervention continues with aerobic exercise led by health coaches via Webex. Classes start in Week 13 with one session per week, increasing to two sessions per week in Weeks 17-28.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA), National Institutes of Health (NIH)
Leads: Indiana University

This content was sourced from clinicaltrials.gov