Brain Connections and Blood Pressure

Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03736434

Enrollment

Registered

2018-11-09

Start date

2018-08-23

Completion date

2020-03-25

Last updated

2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Mild Cognitive Impairment

Keywords

Mindfulness, Blood pressure, Hypertension, Mild Cognitive impairment (MCI), functional Magnetic resonance Imaging (fMRI), Hair cortisol

Brief 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.

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.

Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALEducation 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Masking description

Data collectors masked as to the hypotheses of the study.

Intervention model description

Three aim randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in Resting State Network	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	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	Baseline and 3 months	Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings

Secondary

Measure	Time frame	Description
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change	Baseline and 3 months	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.
Cognitive and Affective Mindfulness Scale Change	Baseline and 3 months	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.
Perceived Stress Scale Change	Baseline and 3 months	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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 by arm

Arm	Count
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.	13
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.	13
Control Group Continue care as usual without intervention.	12
Total	38

Baseline characteristics

Characteristic	Education Group	Control Group	Mindfulness Plus DASH Group	Total
Age, Continuous	71.9 years STANDARD_DEVIATION 3.9	70.8 years STANDARD_DEVIATION 5.5	74.0 years STANDARD_DEVIATION 5.9	72.4 years STANDARD_DEVIATION 5.2
Cognitive and Affective Mindfulness Scale (Mindful Affect)	33.7 score on a scale STANDARD_DEVIATION 6.3	31.2 score on a scale STANDARD_DEVIATION 6	32.1 score on a scale STANDARD_DEVIATION 5.9	31.2 score on a scale STANDARD_DEVIATION 6.6
Diastolic Blood Pressure	78.3 mmHg STANDARD_DEVIATION 12.1	76.3 mmHg STANDARD_DEVIATION 13.3	75.6 mmHg STANDARD_DEVIATION 9.6	76 mmHg STANDARD_DEVIATION 11.5
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q)	58.1 score on a scale STANDARD_DEVIATION 11.1	69.1 score on a scale STANDARD_DEVIATION 8.3	70.0 score on a scale STANDARD_DEVIATION 12	63.6 score on a scale STANDARD_DEVIATION 12.6
Number of chronic conditions	4.5 Chronic Conditions STANDARD_DEVIATION 1.8	4.1 Chronic Conditions STANDARD_DEVIATION 1	5 Chronic Conditions STANDARD_DEVIATION 1.3	4.8 Chronic Conditions STANDARD_DEVIATION 1.4
Number of hypertension medications	1.9 Number of medications STANDARD_DEVIATION 1.2	1.8 Number of medications STANDARD_DEVIATION 1	2.1 Number of medications STANDARD_DEVIATION 0.9	2.0 Number of medications STANDARD_DEVIATION 1.1
Perceived Stress Scale	9.7 score on a scale STANDARD_DEVIATION 6.1	16.1 score on a scale STANDARD_DEVIATION 10.1	10.5 score on a scale STANDARD_DEVIATION 7.1	12 score on a scale STANDARD_DEVIATION 8.1
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	13 Participants	12 Participants	13 Participants	38 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	13 participants	12 participants	13 participants	38 participants
Self-Administered Gerocognitive Examination (SAGE)	14.1 units on a scale STANDARD_DEVIATION 2.6	13.4 units on a scale STANDARD_DEVIATION 3.8	13.3 units on a scale STANDARD_DEVIATION 3.5	13.6 units on a scale STANDARD_DEVIATION 3.3
Sex: Female, Male Female	9 Participants	10 Participants	12 Participants	31 Participants
Sex: Female, Male Male	4 Participants	2 Participants	1 Participants	7 Participants
Systolic Blood Pressure	140.4 mmHg STANDARD_DEVIATION 28.3	139.6 mmHg STANDARD_DEVIATION 12.8	133.6 mmHg STANDARD_DEVIATION 14.4	137.8 mmHg STANDARD_DEVIATION 19.7

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 13	0 / 12
other Total, other adverse events	0 / 13	0 / 13	0 / 12
serious Total, serious adverse events	0 / 13	0 / 13	0 / 12

Outcome results

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