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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIND+SOUL Diet | Experimental | The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIND+SOUL Diet | Other | The MIND+SOUL Diet is an adapted brain-healthy soul food diet. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Health System | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39540187 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MIND+SOUL Diet | The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. MIND+SOUL Diet: The MIND+SOUL Diet is an adapted brain-healthy soul food diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MIND+SOUL Diet | The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. MIND+SOUL Diet: The MIND+SOUL Diet is an adapted brain-healthy soul food diet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who enrolled in the MIND+SOUL pilot and completed baseline assessments were included in the feasibility analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
|
Adverse events were monitored throughout the 12-week intervention period for each participant.
Adverse events were monitored informally during routine check-ins across the 12-week intervention period. One participant reported feeling dehydrated, which they attributed to not having consumed water throughout the day. Another participant reported feeling bloated after consuming foods included in the study diet. These events were recorded during check-ins and monitored by study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIND+SOUL Diet | The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. MIND+SOUL Diet: The MIND+SOUL Diet is an adapted brain-healthy soul food diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Gastrointestinal disorders | Systematic Assessment | Dehydration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashley Shaw | University of Kansas Medical Center | 913-945-5023 | ashaw10@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2022 | Apr 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cardiovascular Risk Factor | Count of Participants | Participants |
|
| Cognitively Normal | Count of Participants | Participants |
|
| No active depression | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | 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. | Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis. | Posted | Mean | Standard Deviation | grams | Assessed at baseline and 12 weeks; 12-week data reported |
|
|
|
| Secondary | 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. | Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis. | Posted | Mean | Standard Deviation | grams | Assessed at baseline and 12 weeks; 12-week data reported |
|
|
|
| Secondary | 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. | Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis. | Posted | Mean | Standard Deviation | cm | Assessed at baseline and 12 weeks; 12-week data reported |
|
|
|
| Secondary | 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. | Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis. | Posted | Mean | Standard Deviation | kg/m^2 | Assessed at baseline and 12 weeks; 12-week data reported |
|
|
|
| Secondary | 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. | Participants who completed both baseline and 12-week assessments for cholesterol were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark. |
|
|
|
| Secondary | 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 | Participants who completed both baseline and 12-week assessments for blood pressure were included in this analysis. | Posted | Mean | Standard Deviation | mmHg | All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark. |
|
|
|
| Secondary | 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. | Participants who completed Veggie Meter assessments at both baseline and 12-week follow-up were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Self-reported dietary intake was assessed at baseline and at the 12-week follow-up. |
|
|
|
| Secondary | 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. | Participants who completed the NHANES Dietary Screener at both baseline and 12-week follow-up were included in the analysis. | Posted | Mean | Standard Deviation | cups per day | Self-reported dietary intake was assessed at baseline and at the 12-week follow-up |
|
|
|
| Secondary | 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. | Participants who completed NIH Toolbox cognitive assessments at both baseline and 12-week follow-up were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale from 0 to 200 | Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point. |
|
|
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| Secondary | 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. | No data is available for this outcome. The primary investigator did not build the database to include recording of participant-reported reasons for for non-enrollment, therefore the data was not collected. | Posted | Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked. |
|
|
| Secondary | 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. | Participants who completed the Visual Analog Scale for satisfaction at the 12-week follow-up were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Satisfaction assessment will be conducted at the 12-week mark. |
|
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| Secondary | 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. | Participants who completed the post-intervention acceptability survey at the 12-week follow-up were included in the analysis. | Posted | Mean | Standard Deviation | Score on scale | Acceptability assessment will be conducted at the 12-week mark. |
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| 29 |
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| 29 |
| 2 |
| 29 |
| Bloating | Metabolism and nutrition disorders | Systematic Assessment | Bloating |
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