Clinical trial NCT05414682: Brain Healthy Soul Food Diet Intervention Among Older African Americans
Official title: Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cognitive Decline
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 29
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention.

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 brain healthy soul food diet intervention. As secondary outcomes, this study aims to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older AA to form the basis of estimating power and sample size for a future full-scale randomized controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Feasibility: Retention rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Composition
timeFrame: Body composition will be collected at baseline and at the 12-week mark.
measure: Cardiovascular risk profile
timeFrame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
measure: Nutritional Health Status
timeFrame: Nutritional health status change will be measured at baseline and at the 12-week mark
measure: Cognitive Function
timeFrame: Cognitive function assessments be conducted at baseline and at the 12-week mark.
measure: Feasibility: Reasons for Refusal
timeFrame: Reasons for refusal to participate will be measured throughout the recruitment period which will last approximately three months.
measure: Satisfaction - Visual analog scale
timeFrame: Satisfaction assessment will be conducted at the 12-week mark.
measure: Acceptability
timeFrame: Acceptability assessment will be conducted at the 12-week mark.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
References: