Status:
COMPLETED
Brain Healthy Soul Food Diet Intervention Among Older African Americans
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Cardiovascular Diseases
Cognitive Decline
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile,...
Detailed Description
This is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older AA (n=30). Specifically, this study aims to evaluate the feasibility and acceptability of the b...
Eligibility Criteria
Inclusion
- Identify as African American or Black
- Age 55 and older
- English Proficient
- 1 or more of the following CVD risk factors (high blood pressure, high cholesterol, overweight/obesity with a BMI of 25 or more)
- Cognitively Normal with an AD8 \<2 (normal cognition)
Exclusion
- No CVD risk factors
- AD8 equal to or greater than 2
- Existing diet plan prescribed by a clinician
- Non menopausal (because of DXA scan)
- No internet connection
- Uncontrolled hypertension, by history, or as indicated by supine systolic blood pressure \>165 mmHg or diastolic blood pressure \>95 mmHg at the baseline visit. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension
- Neurological diseases that impact cognition
- Other medical conditions likely to be negatively impacted by a diet change or that could confound the study data
- Unable or unwilling to provide written consent
- PI determination that study is unsafe or unsuitable
- Active depression as determined by a score of 5 or above on the PHQ9 and deemed to be clinically significant by the medical monitor
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05414682
Start Date
August 1 2022
End Date
November 1 2023
Last Update
October 17 2025
Active Locations (1)
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1
University of Kansas Health System
Kansas City, Kansas, United States, 66160