Cardiovascular Diseases, Cognitive Decline
Conditions
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.
Interventions
The MIND+SOUL Diet is an adapted brain-healthy soul food diet.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Retention Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Android Fat Mass | 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. |
| Waist Circumference | 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. |
| Body Mass Index | 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. |
| Total Cholesterol | 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. |
| Systolic Blood Pressure | 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 |
| Total Fat Mass | 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. |
| Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) | 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. |
| Cognitive Function | 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. |
| Feasibility: Reasons for Refusal | 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. |
| Satisfaction - Visual Analog Scale | 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. |
| Acceptability | 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. |
| Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | MIND+SOUL Diet |
|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 6.69 |
| Cardiovascular Risk Factor high blood pressure | 29 Participants |
| Cardiovascular Risk Factor high cholesterol | 29 Participants |
| Cardiovascular Risk Factor overweight (BMI greater or equal to 25) | 29 Participants |
| Cognitively Normal | 29 Participants |
| No active depression | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 2 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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.
Time frame: 12 weeks
Population: All participants who enrolled in the MIND+SOUL pilot and completed baseline assessments were included in the feasibility analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIND+SOUL Diet | Feasibility: Retention Rate | 28 percentage of participants |
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.
Time frame: Acceptability assessment will be conducted at the 12-week mark.
Population: Participants who completed the post-intervention acceptability survey at the 12-week follow-up were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIND+SOUL Diet | Acceptability | 91.8 Score on scale | Standard Deviation 11.4 |
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.
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Population: Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MIND+SOUL Diet | Android Fat Mass | 3,301.2 grams |
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.
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Population: Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIND+SOUL Diet | Body Mass Index | 34.6 kg/m^2 | Standard Deviation 7.9 |
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.
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.
Population: Participants who completed NIH Toolbox cognitive assessments at both baseline and 12-week follow-up were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIND+SOUL Diet | Cognitive Function | 90.2 Scores on a scale from 0 to 200 | Standard Deviation 4.1 |
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.
Time frame: Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.
Population: 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.
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.
Time frame: Satisfaction assessment will be conducted at the 12-week mark.
Population: Participants who completed the Visual Analog Scale for satisfaction at the 12-week follow-up were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIND+SOUL Diet | Satisfaction - Visual Analog Scale | 9.4 Score on a scale | Standard Deviation 1.2 |
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.
Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up
Population: Participants who completed the NHANES Dietary Screener at both baseline and 12-week follow-up were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND+SOUL Diet | Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) | Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) at 12 weeks | 0.891 cups per day | Standard Deviation 0.6052 |
| MIND+SOUL Diet | Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) | Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) at baseline | 0.626 cups per day | Standard Deviation 0.5634 |
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.
Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.
Population: Participants who completed Veggie Meter assessments at both baseline and 12-week follow-up were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND+SOUL Diet | Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) | Skin Carotenoid Score (Veggie Meter) at baseline | 245.2 score on a scale | Standard Deviation 96.45 |
| MIND+SOUL Diet | Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) | Skin Carotenoid Score (Veggie Meter) at 12 weeks | 270.9 score on a scale | Standard Deviation 91.24 |
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
Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Population: Participants who completed both baseline and 12-week assessments for blood pressure were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND+SOUL Diet | Systolic Blood Pressure | Systolic blood pressure at baseline | 127.31 mmHg | Standard Deviation 12.421 |
| MIND+SOUL Diet | Systolic Blood Pressure | Systolic blood pressure at 12 weeks | 132.40 mmHg | Standard Deviation 14.602 |
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.
Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Population: Participants who completed both baseline and 12-week assessments for cholesterol were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND+SOUL Diet | Total Cholesterol | Cholesterol at baseline | 177.5 mg/dL | Standard Deviation 36.46 |
| MIND+SOUL Diet | Total Cholesterol | Cholesterol at 12-weeks | 181.5 mg/dL | Standard Deviation 53.88 |
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.
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Population: Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MIND+SOUL Diet | Total Fat Mass | 37,395.1 grams |
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.
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Population: Participants who completed both baseline and 12-week DXA body composition assessments were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIND+SOUL Diet | Waist Circumference | 98.5 cm | Standard Deviation 14 |