HypertensionNCT03736434
Brain Connections and Blood Pressure
A study testing Mindfulness and DASH Diet Education and Education group in people with Hypertension and Mild Cognitive Impairment, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Mild Cognitive Impairment
- What is being tested?
- Mindfulness and DASH Diet Education and Education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2018to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of hypertension with or without medication use
- Diagnosis of Alzheimer's disease or related dementia disorder or, if no formal diagnosis of Alzheimer's disease, then a Self-Assessment Gerocognitive Evaluation score 17-10 or a Montreal Cognitive Assessment Screen 25-19
Who cannot join
- Unable to understand spoken English
- Expect to move out of the area within six months
- fMRI imaging contraindicated (history of shrapnel, metal in the body, heart pacemaker, heart defibrillator, metal in the eye, gunshot wound, or some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices) or claustrophobia. However, the participant can be included in the study without fMRI.
- Self-reported history of a stroke
- <6 on the Brief Assessment of Understanding of the Study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official title: Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
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.
Read the detailed description
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.
- Conditions
- Hypertension, Mild Cognitive Impairment
- Being tested
- Mindfulness and DASH Diet Education, Education group
- Keywords
- Mindfulness, Blood pressure, Hypertension, Mild Cognitive impairment (MCI), functional Magnetic resonance Imaging (fMRI), Hair cortisol
- Medical subject headings
- Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and DASH Diet EducationBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness plus DASH group | Experimental | Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) Receives: Behavioral: Mindfulness and DASH Diet Education; Behavioral: Education group |
| 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) Receives: Behavioral: Mindfulness and DASH Diet Education; Behavioral: Education group |
| Control Group | No intervention | Continue care as usual without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and 3 months
Secondary outcomes (3)
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.
Measured: Baseline and 3 months
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."
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start23 Aug 2018
- Primary completion17 Jan 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three aim randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy D. Wright, Ohio State University
- Investigators
- Kathy D Wright, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736434
- Sponsor's protocol ID
- 2018H0136
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2018
- Last updated
- 1 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
- ClinicalTrials.gov ID
- NCT03736434
- Acronym / sponsor ID
- 2018H0136
- Conditions
- Hypertension, Mild Cognitive Impairment
- Keywords
- Mindfulness, Blood pressure, Hypertension, Mild Cognitive impairment (MCI), functional Magnetic resonance Imaging (fMRI), Hair cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 1 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Three aim randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness plus DASH group | Experimental | Behavioral: Mindfulness and DASH Diet Education, Behavioral: Education groupReceives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions) |
| Education Group | Active comparator | Behavioral: Mindfulness and DASH Diet Education, Behavioral: Education groupThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Diagnosis of hypertension with or without medication use
- Diagnosis of Alzheimer's disease or related dementia disorder or, if no formal diagnosis of Alzheimer's disease, then a Self-Assessment Gerocognitive Evaluation score 17-10 or a Montreal Cognitive Assessment Screen 25-19
Key exclusion criteria (5 listed)
- Unable to understand spoken English
- Expect to move out of the area within six months
- fMRI imaging contraindicated (history of shrapnel, metal in the body, heart pacemaker, heart defibrillator, metal in the eye, gunshot wound, or some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices) or claustrophobia. However, the participant can be included in the study without fMRI.
- Self-reported history of a stroke
- <6 on the Brief Assessment of Understanding of the Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and DASH Diet EducationMindfulness 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. | Behavioural | Education Group, Mindfulness plus DASH group |
| Education groupThe 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. | Behavioural | Education Group, Mindfulness plus DASH group |
Primary outcome
Change in Resting State Network
Time frame: Baseline and 3 months
functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network
Change in Systolic Blood Pressure
Time frame: Baseline and 3 months
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
Change in Diastolic Blood Pressure
Time frame: Baseline and 3 months
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
3 secondary outcomes
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change
Time frame: Baseline and 3 months
Cognitive and Affective Mindfulness Scale Change
Time frame: Baseline and 3 months
Perceived Stress Scale Change
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy D Wright, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and DASH Diet Education and Education group in people with Hypertension and Mild Cognitive Impairment, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting State Network (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.