Brain Healthy Soul Food Diet Intervention Among Older African Americans (MIND+SOUL Diet)

Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cognitive Decline
• Intervention / Treatment: Other: MIND+SOUL Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIND+SOUL Diet; The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks.	Other: MIND+SOUL Diet; The MIND+SOUL Diet is an adapted brain-healthy soul food diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Retention Rate	Feasibility will be assessed by retention rate. This will be calculated as the percentage of participants who complete all aspects of the intervention including cooking classes and coach directed dietary call support.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Fat Mass	Total fat mass was assessed using dual-energy X-ray absorptiometry (DXA) to measure total fat mass. Assessments were conducted at baseline and again at the 12-week follow-up. The values reported below reflect the 12-week follow-up, with changes calculated from baseline to 12 weeks.	Assessed at baseline and 12 weeks; 12-week data reported
Android Fat Mass	Android fat mass was assessed using dual-energy X-ray absorptiometry (DXA) to measure android fat mass. Assessments were conducted at baseline and again at the 12-week follow-up. The values reported below reflect the 12-week follow-up, with changes calculated from baseline to 12 weeks.	Assessed at baseline and 12 weeks; 12-week data reported
Waist Circumference	Waist circumference was measured using a standard tape measure at baseline and 12 weeks. Data reported reflect 12-week follow-up values for participants who completed both time points.	Assessed at baseline and 12 weeks; 12-week data reported
Body Mass Index	Body mass index was calculated using measured height and weight at baseline and 12 weeks. The value below reflects BMI at the 12-week follow-up for participants who completed both assessments.	Assessed at baseline and 12 weeks; 12-week data reported
Total Cholesterol	Cardiovascular risk profile will be measured by cholesterol. Cholesterol will be measured using the PTS Diagnostics Cardiocheck Plus Analyzer Cholesterol and Glucose Check.	All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Systolic Blood Pressure	Cardiovascular risk profile will be measured by systolic blood pressure. Blood pressure will be measured using the Omron 5 series blood pressure monitor. C	All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter)	Skin carotenoid levels were assessed using the Veggie Meter®, which uses reflection spectroscopy to provide an objective measure of carotenoid-rich fruit and vegetable intake. Scores typically range from 0 to 800. Higher scores indicate higher carotenoid levels and greater intake of fruits and vegetables. Changes were evaluated from baseline to 12 weeks.	Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.
Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener)	Self-reported fruit and vegetable intake was assessed using the NHANES Dietary Screener Questionnaire (DSQ). The DSQ estimates average daily intake in cups per day, based on participant-reported consumption over the past 30 days. There is no fixed score range; higher estimated intake reflects greater fruit and vegetable consumption and better nutritional health. Changes were assessed from baseline to 12 weeks.	Self-reported dietary intake was assessed at baseline and at the 12-week follow-up
Cognitive Function	Cognitive function was assessed using the NIH Toolbox Cognition Battery. The following assessments were administered to evaluate specific cognitive domains: NIH Toolbox List Sorting Working Memory Test (working memory), Picture Vocabulary Test (language), Oral Reading Recognition Test (reading), Pattern Comparison Processing Speed Test (processing speed), and Flanker Inhibitory Control and Attention Test (executive function). Each test yields a fully normed T-score ranging from 0 to 200, with a normative mean of 100 and a standard deviation of 15. Higher scores reflect better cognitive performance. This outcome specifically focuses on changes in executive function, as measured by the Flanker Inhibitory Control and Attention Test. Scores were collected at two time points: baseline and 12 weeks. The value reported in the data table reflects the mean score at 12 weeks.	Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.
Feasibility: Reasons for Refusal	Feasibility was planned to be assessed by tracking reasons for refusal to participate during the recruitment phase. Staff aimed to document participant-reported reasons for non-enrollment during initial outreach and screening efforts, however staff did not document participant-reported reasons for non-enrollment.	Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.
Satisfaction - Visual Analog Scale	Satisfaction with the MIND+SOUL diet was assessed using a Visual Analog Scale (VAS) for overall program satisfaction. The Visual Analog Scale is a single-item self-report tool ranging from 0 to 10, where 0 indicates the least amount of satisfaction and 10 indicates the highest level of satisfaction. Higher scores represent better outcomes, meaning greater satisfaction with the intervention.	Satisfaction assessment will be conducted at the 12-week mark.
Acceptability	Acceptability of the MIND+SOUL intervention was assessed using a REDCap-administered online survey developed to evaluate participant perceptions across five domains: affective attitude, burden, ethicality, perceived effectiveness, and self-efficacy. The survey includes 20 items, each scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 20 to 100, with higher scores indicating greater acceptability of the intervention. Scores were collected at the 12-week follow-up.	Acceptability assessment will be conducted at the 12-week mark.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Publications and helpful links

General Publications

• Shaw AR, Honea R, Mudaranthakam DP, Young K, Vidoni ED, Morris JK, Billinger S, Key MN, Berkley-Patton J, Burns JM. Feasibility of the MIND+SOUL Culturally Tailored Brain Healthy Diet: A Pilot Study. Am J Lifestyle Med. 2024 Oct 23:15598276241296052. doi: 10.1177/15598276241296052. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Cardiovascular Diseases
• Other Study ID Numbers: 148307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No