Brain Healthy Soul Food Diet Intervention Among Older African Americans

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, Cognitive Decline

Intervention / Treatment
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* Other: MIND+SOUL Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| Body Composition | Body composition will be measured using dual energy x-ray absorptiometry (DXA)5,6 , height, weight, and waist circumference. Using DXA we will specifically be focusing on changes in fat tissue from baseline to the 12-week mark of the MIND+SOUL intervention. | Body composition will be collected at baseline and at the 12-week mark. | 
| Cardiovascular risk profile | Cardiovascular risk profile will be measured by 2 items; blood pressure and cholesterol. Blood pressure will be measured using the Omron 5 series blood pressure monitor. 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. | 
| Nutritional Health Status | : Nutritional health status change will be measured using the NHANES dietary screener questionnaire and the skin carotenoid assessment (Veggie Meter). Using the dietary screener questionnaire, we will specifically be focusing on changes in fruit and vegetable consumptions. Using the veggie meter, we will specifically be focusing on changes in skin carotenoid levels | Nutritional health status change will be measured at baseline and at the 12-week mark | 
| Cognitive Function | Cognitive function will be measured using the NIH Toolbox to assess the following domains: memory, language, reading, vocabulary, processing speed, and executive function. Specifically the following tests will be administered: NIH-TB List Sorting Working Memory Test, NIH-TB Picture Vocabulary Test, NIH-TB Oral Reading Recognition Test, and the NIH-TB Pattern Comparison Processing Speed Test, and NIH-TB Flanker Inhibitory Control and Attention. For cognitive function we will be specifically focusing on changes in executive function. | Cognitive function assessments be conducted at baseline and at the 12-week mark. | 
| Feasibility: Reasons for Refusal | Feasibility will be assessed by reasons for refusal to participate. Reasons for refusal to participate will be documented. | Reasons for refusal to participate will be measured throughout the recruitment period which will last approximately three months. | 
| Satisfaction - Visual analog scale | Satisfaction with MIND+SOUL diet will be measured using a visual analog scale. The visual analog scale will be a score from 0, which indicates the least amount of satisfaction, to 10, which indicates the most amount of satisfaction. | Satisfaction assessment will be conducted at the 12-week mark. | 
| Acceptability | Acceptability will be assessed using a REDCap online surveys. The acceptability survey will evaluate the affective attitude, burden, ethicality, perceived effectiveness, and self-efficacy of the intervention. Each question will be scored from 1 (strongly disagree) to 5 (strong agree) with the total survey score ranging from 20 to 100. | Acceptability assessment will be conducted at the 12-week mark. |