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Brain Connections and Blood Pressure

Primary Purpose

Hypertension, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness and DASH Diet Education
Education group
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Mindfulness, Blood pressure, Hypertension, Mild Cognitive impairment (MCI), functional Magnetic resonance Imaging (fMRI), Hair cortisol

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ohio State University College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness plus DASH group

Education Group

Control Group

Arm Description

Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)

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)

Continue care as usual without intervention.

Outcomes

Primary Outcome Measures

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
Change in Systolic and Diastolic Blood Pressure
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
December 16, 2020
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03736434
Brief Title
Brain Connections and Blood Pressure
Official Title
Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Mild Cognitive Impairment
Keywords
Mindfulness, Blood pressure, Hypertension, Mild Cognitive impairment (MCI), functional Magnetic resonance Imaging (fMRI), Hair cortisol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three aim randomized controlled trial
Masking
ParticipantCare Provider
Masking Description
Data collectors masked as to the hypotheses of the study.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness plus DASH group
Arm Type
Experimental
Arm Description
Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)
Arm Title
Education Group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Continue care as usual without intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and DASH Diet Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Resting State Network
Description
functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network
Time Frame
Baseline and 3 months
Title
Change in Systolic and Diastolic Blood Pressure
Description
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy D Wright, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Nursing
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Connections and Blood Pressure

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