Brain Healthy Soul Food Diet Intervention Among Older African Americans

Cardiovascular Diseases Clinical Trial

— MIND+SOUL Diet  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05414682
• Other study ID #: 148307
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• MIND+SOUL Diet
The MIND+SOUL Diet is an adapted brain-healthy soul food diet.

Locations

Country	Name	City	State
United States	University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.