MIND Foods and Aerobic Training in Black Adults With HTN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorIndiana University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Fluent in English
Marion County resident
35-75 years
Self-identified non-Hispanic and Black/African-American/biracial including African-American
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Usual Care (EUC)
BehavioralEnhanced Usual Care (EUC) includes 5 weeks of hypertension classes.
Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)
BehavioralFood 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 28 post intervention start date2
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.
Time frame
Week 52 post intervention start dateSecondary outcomes
1
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.
Time frame
From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.2
Participant adherence to treatment.
Number of training sessions attended divided by the the total number of sessions available.
Time frame
From date of randomization until the date of the final training session or the end of the 28-week intervention, whichever came first.3
Participant adherence to outcome assessments.
Number of participants completing the outcome assessments divided by the total number randomized.
Time frame
End of follow-up at 52-weeks.4
Number of participants with study-related adverse events (AE) by treatment arm.
Adverse event count for each study arm
Time frame
From enrollment through end of follow-up at 52-weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov