Brain Connections and Blood Pressure

NCT03736434 | Completed Results DMC

• 1 other identifier: 2018H0136
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change

  Baseline and 3 months

• Cognitive and Affective Mindfulness Scale Change

  Baseline and 3 months

• Perceived Stress Scale Change

  Baseline and 3 months

Study Arms (3)

Mindfulness plus DASH group

EXPERIMENTAL

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

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)

Behavioral: Mindfulness and DASH Diet Education; Behavioral: Education group

Control Group

NO INTERVENTION

Continue care as usual without intervention.

Interventions

Mindfulness and DASH Diet Education BEHAVIORAL

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; Mindfulness plus DASH group

Education group BEHAVIORAL

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.

Education Group; Mindfulness plus DASH group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypertension; Cognitive Dysfunction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Kathy Wright
• Organization: The Ohio State University College of Nursing

wright.2104@osu.edu

614-292-0309

Study Officials

• Kathy D Wright, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Data collectors masked as to the hypotheses of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three aim randomized controlled trial

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: August 23, 2018
• Primary Completion: January 17, 2020
• Study Completion: March 25, 2020
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)