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This pilot randomized controlled study evaluates Mindfulness and DASH Diet resting state network and blood pressure in 36 (n=12 intervention; n=12 attention control; n = 12 control) Black and African American older adults with early Alzheimer's disease and related dementia disorders and hypertension.
The purpose of this pilot randomized controlled study is to adapt a previously tested intervention to improve resting state network and blood pressure in 36 (n=12 intervention; n=12 attention control; n = 12 control) Black and African American older adults with early Alzheimer's disease and related dementia disorders and hypertension.
The study aims are to:
A.1. Establish the feasibility and acceptability of the intervention in Black and African Americans with Alzheimer's disease and related dementia disorders and hypertension.
H1: The intervention will be feasible and acceptable to Black and African Americans with Alzheimer's disease and related dementia disorders. Feasibility will be measured by recruitment, attendance, and attrition. Acceptability will be measured by a garnering feedback in a debriefing after each session.
A.2. Determine the effect size of the difference between the intervention, attention control, and control groups in resting state network connectivity and working memory and blood pressure to inform the sample size for the R01 trial.
H2: We hypothesize that compared to both control groups; the intervention group will have greater improvement in process measures of self-management mechanisms (self-efficacy, self-regulation, and emotion regulation), chronic stress, diet, and physical activity. The functional magnetic resonance imaging and blood pressure will be obtained at baseline and 3 months. The intervention group (Mindfulness + DASH) will have improved resting state network connectivity and blood pressure as compared to the attention control (2-hour group social time and brief lecture on a non-diet/mindfulness topic such as personal safety, fire safety, and disaster preparedness) and the control group (care as usual with no intervention). The Center for Cognitive and Behavioral Brain Imaging, Arts & Sciences co-investigators will analyze imaging data using their newly published statistical network model to quantify the subnetwork structures of the resting state network and evaluate changes of their topological properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness plus DASH group | Experimental | Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) |
|
| Education Group | Active Comparator | The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions) |
|
| Control Group | No Intervention | Continue care as usual without intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness and DASH Diet Education | Behavioral | Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting State Network | functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network | Baseline and 3 months |
| Change in Systolic Blood Pressure | Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings | Baseline and 3 months |
| Change in Diastolic Blood Pressure | Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change | DASH Q has 11 items focused on the consumption of DASH foods (e.g., fruits, nuts, and vegetables) in the past 7 days (Cronbach α = .83). The reference range for the DASH Q was 0-105 with higher scores indicating greater adherence to DASH diet. | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy D Wright, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Nursing | Columbus | Ohio | 43210 | United States |
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No participants were excluded. The participants were randomized into groups MIM DASH, non-hypertensive edcuation attention only, or true control. Unit of analysis is participants, not groups.
Participants were recruited (August 2018-August 2019) from area clinics and the local African American Churches, The Charitable Pharmacy of Central Ohio. Additionally, participants will be recruited from the college of nursing Total Health and Wellness Center, local senior centers that service the African American community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Plus DASH Group | Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
| FG001 | Education Group | The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
| FG002 | Control Group | Continue care as usual without intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Plus DASH Group | Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
| 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 | Change in Resting State Network | functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network | This data point was unable to be collected, not able to complete MRIs. | Posted | Baseline and 3 months |
|
3 months post intervention
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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 | Mindfulness Plus DASH Group | Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathy Wright | The Ohio State University College of Nursing | 614-292-0309 | wright.2104@osu.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 | Feb 19, 2019 | Oct 25, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2019 | Oct 25, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Three aim randomized controlled trial
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Data collectors masked as to the hypotheses of the study.
|
| Education group | Behavioral | The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
|
| Cognitive and Affective Mindfulness Scale Change |
The Cognitive and Affective Mindfulness Scale (Cronbach α = .77)17 has 12 questions (reference range 0-48, higher scores indicate greater mindfulness affect) on a Likert scale regarding daily experiences such as "I rush through activities without being really attentive to them." |
| Baseline and 3 months |
| Perceived Stress Scale Change | The Perceived Stress Scale has 10-items reference range 0-30 regarding stress over the past month (Cronbach α = 0.83).1The cut point for moderate to high stress is 12 or more for persons aged 65 and older. | Baseline and 3 months |
| BG001 | Education Group | The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
| BG002 | Control Group | Continue care as usual without intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Self-Administered Gerocognitive Examination (SAGE) | Self-Administered Gerocognitive Examination (SAGE), specifically designed to screen for mild cognitive impairment and early dementia. SAGE covers cognitive domains of orientation, language, memory, executive function, calculations, abstraction, and visuospatial abilities. The psychometric properties have been well validated with a 0.84 Spearman rank correlation between SAGE and a 1-day neuropsychiatric battery. Scores range from 0-22, score of 17 opr above is considered normal. Therefore higher scores indicate better outcomes. | Mean | Standard Deviation | units on a scale |
|
| Number of chronic conditions | Mean | Standard Deviation | Chronic Conditions |
|
| Number of hypertension medications | Total number of medications participant is prescribed for hypertension | Mean | Standard Deviation | Number of medications |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) | DASH Q has 11 items focused on the consumption of DASH foods (e.g., fruits, nuts, and vegetables) in the past 7 days (Cronbach α = .83). The reference range for the DASH Q was 0-105 with higher scores indicating greater adherence to DASH diet. | Mean | Standard Deviation | score on a scale |
|
| Cognitive and Affective Mindfulness Scale (Mindful Affect) | The Cognitive and Affective Mindfulness Scale (Cronbach α = .77)17 has 12 questions (reference range 0-48, higher scores indicate greater mindfulness affect) on a Likert scale regarding daily experiences such as "I rush through activities without being really attentive to them." | Mean | Standard Deviation | score on a scale |
|
| Perceived Stress Scale | The Perceived Stress Scale has 10-items reference range 0-30 regarding stress over the past month (Cronbach α = 0.83).The cut point for moderate to high stress is 12 or more for persons aged 65 and older. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Education Group | The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. |
| OG002 | Control Group | Continue care as usual without intervention. |
|
| Primary | Change in Systolic Blood Pressure | Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 months |
|
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| Primary | Change in Diastolic Blood Pressure | Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 months |
|
|
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| Secondary | Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change | DASH Q has 11 items focused on the consumption of DASH foods (e.g., fruits, nuts, and vegetables) in the past 7 days (Cronbach α = .83). The reference range for the DASH Q was 0-105 with higher scores indicating greater adherence to DASH diet. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| Secondary | Cognitive and Affective Mindfulness Scale Change | The Cognitive and Affective Mindfulness Scale (Cronbach α = .77)17 has 12 questions (reference range 0-48, higher scores indicate greater mindfulness affect) on a Likert scale regarding daily experiences such as "I rush through activities without being really attentive to them." | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| Secondary | Perceived Stress Scale Change | The Perceived Stress Scale has 10-items reference range 0-30 regarding stress over the past month (Cronbach α = 0.83).1The cut point for moderate to high stress is 12 or more for persons aged 65 and older. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Education Group | The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions) Mindfulness and DASH Diet Education: Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and "hands-on" activities will be done to deliver DASH diet guidelines. Education group: The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Control Group | Continue care as usual without intervention. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001523 |
| Mental Disorders |