NCT06152614

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Nov 2023May 2028

First Submitted

Initial submission to the registry

November 2, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

November 2, 2023

Last Update Submit

February 3, 2026

Conditions

Cognitive DeclineHypertensionDietAerobic Exercise

Keywords

nutritioncookingexercisehypertension

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Average participant self-ratings of intervention acceptability.

    From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.

  • Participant adherence to treatment.

    From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.

  • Participant adherence to outcome assessments.

    End of follow-up at 52-weeks.

  • Number of participants with study-related adverse events (AE) by treatment arm.

    From enrollment through end of follow-up at 52-weeks.

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care (EUC)

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

EXPERIMENTAL

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.

Behavioral: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

Interventions

Enhanced Usual Care (EUC)BEHAVIORAL

Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.

Enhanced Usual Care (EUC)
Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)BEHAVIORAL

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.

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • Marion County resident
  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionHypertensionMotor Activity

Interventions

Cooking

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • Daniel O Clark, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel O Clark, PhD

CONTACT

317-274-9292daniclar@iu.edu

Lyndsi R Moser, BA, CCRP

CONTACT

317-963-7301lrhabegg@iupui.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 30, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)