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Completed

NCT Number: NCT05414682

Brain Healthy Soul Food Diet Intervention Among Older African Americans

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIND+SOUL Diet

Other

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

Primary outcomes

  1. Feasibility: Retention Rate

    Time frame: 12 weeks

    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 outcomes

  1. Total Fat Mass

    Time frame: Assessed at baseline and 12 weeks; 12-week data reported

    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.

  2. Android Fat Mass

    Time frame: Assessed at baseline and 12 weeks; 12-week data reported

    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.

  3. Waist Circumference

    Time frame: Assessed at baseline and 12 weeks; 12-week data reported

    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.

  4. Body Mass Index

    Time frame: Assessed at baseline and 12 weeks; 12-week data reported

    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.

  5. Total Cholesterol

    Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.

    Cardiovascular risk profile will be measured by cholesterol. Cholesterol will be measured using the PTS Diagnostics Cardiocheck Plus Analyzer Cholesterol and Glucose Check.

  6. Systolic Blood Pressure

    Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.

    Cardiovascular risk profile will be measured by systolic blood pressure. Blood pressure will be measured using the Omron 5 series blood pressure monitor. C

  7. Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter)

    Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.

    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.

  8. Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener)

    Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up

    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.

  9. Cognitive Function

    Time frame: Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.

    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.

  10. Feasibility: Reasons for Refusal

    Time frame: Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.

    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.

  11. Satisfaction - Visual Analog Scale

    Time frame: Satisfaction assessment will be conducted at the 12-week mark.

    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.

  12. Acceptability

    Time frame: Acceptability assessment will be conducted at the 12-week mark.

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: MIND+SOUL Diet

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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