Brain Connections and Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Mindfulness and DASH Diet Education; Behavioral: Education group

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness plus DASH group; Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)	Behavioral: 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.; Behavioral: 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.
Active Comparator: 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)	Behavioral: 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.; Behavioral: 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.
No Intervention: Control Group; Continue care as usual without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Kathy D Wright, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Mindfulness; Blood pressure; Hair cortisol; Mild Cognitive impairment (MCI); functional Magnetic resonance Imaging (fMRI)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Hypertension; Cognitive Dysfunction
• Other Study ID Numbers: 2018H0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No