Brain Connections and Blood Pressure

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Hypertension
• Interventions: Behavioral: Mindfulness and DASH Diet Education; Behavioral: Education group

• Registration Number: NCT03736434
• Lead Sponsor: Ohio State University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-23
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Primary Completion: 2020-01-17
• Study Completion: 2020-03-25
• Results First Submitted: 2023-06-09
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Results First Posted: 2024-11-01
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness plus DASH group	Mindfulness and DASH Diet Education	Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)
Education Group	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)
Education Group	Mindfulness and DASH Diet Education	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 plus DASH group	Education group	Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Ohio State University College of Nursing; 🇺🇸 Columbus, Ohio, United States