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

Primary Purpose

Cardiovascular Diseases, Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIND+SOUL Diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIND+SOUL Diet

Arm Description

The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
Feasibility: Reasons for Refusal
Feasibility will be assessed by reasons for refusal to participate. Reasons for refusal to participate will be documented.
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.
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.

Full Information

First Posted
May 19, 2022
Last Updated
May 2, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05414682
Brief Title
Brain Healthy Soul Food Diet Intervention Among Older African Americans
Acronym
MIND+SOUL Diet
Official Title
Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIND+SOUL Diet
Arm Type
Experimental
Arm Description
The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks.
Intervention Type
Other
Intervention Name(s)
MIND+SOUL Diet
Intervention Description
The MIND+SOUL Diet is an adapted brain-healthy soul food diet.
Primary Outcome Measure Information:
Title
Feasibility: Retention rate
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body Composition
Description
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.
Time Frame
Body composition will be collected at baseline and at the 12-week mark.
Title
Cardiovascular risk profile
Description
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.
Time Frame
All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Title
Nutritional Health Status
Description
: 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
Time Frame
Nutritional health status change will be measured at baseline and at the 12-week mark
Title
Cognitive Function
Description
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.
Time Frame
Cognitive function assessments be conducted at baseline and at the 12-week mark.
Title
Feasibility: Reasons for Refusal
Description
Feasibility will be assessed by reasons for refusal to participate. Reasons for refusal to participate will be documented.
Time Frame
Reasons for refusal to participate will be measured throughout the recruitment period which will last approximately three months.
Title
Satisfaction - Visual analog scale
Description
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.
Time Frame
Satisfaction assessment will be conducted at the 12-week mark.
Title
Acceptability
Description
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.
Time Frame
Acceptability assessment will be conducted at the 12-week mark.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Shaw, PhD
Phone
913-588-0555
Email
ashaw10@kumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Healthy Soul Food Diet Intervention Among Older African Americans

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