Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152614
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-02
Brief Title:
MIND Foods and Aerobic Training in Black Adults With HTN
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
MIND Foods and Aerobic Training in Black Adults With HTN An ADRD Prevention Pilot RCT
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAT
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG076685 | NIH | None | httpsreporternihgovquickSearchR01AG076685 |