Trial Outcomes & Findings for Brain Connections and Blood Pressure (NCT NCT03736434)

NCT ID: NCT03736434

Last Updated: 2024-11-01

Results Overview

functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2024-11-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
Control Group
Continue care as usual without intervention.
Overall Study
STARTED
13
13
12
Overall Study
COMPLETED
12
13
6
Overall Study
NOT COMPLETED
1
0
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Connections and Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Total
n=38 Participants
Total of all reporting groups
Age, Continuous
74.0 years
STANDARD_DEVIATION 5.9 • n=5 Participants
71.9 years
STANDARD_DEVIATION 3.9 • n=7 Participants
70.8 years
STANDARD_DEVIATION 5.5 • n=5 Participants
72.4 years
STANDARD_DEVIATION 5.2 • n=4 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
9 Participants
n=7 Participants
10 Participants
n=5 Participants
31 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
7 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=5 Participants
13 Participants
n=7 Participants
12 Participants
n=5 Participants
38 Participants
n=4 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
13 participants
n=5 Participants
13 participants
n=7 Participants
12 participants
n=5 Participants
38 participants
n=4 Participants
Self-Administered Gerocognitive Examination (SAGE)
13.3 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
14.1 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
13.4 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
13.6 units on a scale
STANDARD_DEVIATION 3.3 • n=4 Participants
Number of chronic conditions
5 Chronic Conditions
STANDARD_DEVIATION 1.3 • n=5 Participants
4.5 Chronic Conditions
STANDARD_DEVIATION 1.8 • n=7 Participants
4.1 Chronic Conditions
STANDARD_DEVIATION 1.0 • n=5 Participants
4.8 Chronic Conditions
STANDARD_DEVIATION 1.4 • n=4 Participants
Number of hypertension medications
2.1 Number of medications
STANDARD_DEVIATION 0.9 • n=5 Participants
1.9 Number of medications
STANDARD_DEVIATION 1.2 • n=7 Participants
1.8 Number of medications
STANDARD_DEVIATION 1.0 • n=5 Participants
2.0 Number of medications
STANDARD_DEVIATION 1.1 • n=4 Participants
Systolic Blood Pressure
133.6 mmHg
STANDARD_DEVIATION 14.4 • n=5 Participants
140.4 mmHg
STANDARD_DEVIATION 28.3 • n=7 Participants
139.6 mmHg
STANDARD_DEVIATION 12.8 • n=5 Participants
137.8 mmHg
STANDARD_DEVIATION 19.7 • n=4 Participants
Diastolic Blood Pressure
75.6 mmHg
STANDARD_DEVIATION 9.6 • n=5 Participants
78.3 mmHg
STANDARD_DEVIATION 12.1 • n=7 Participants
76.3 mmHg
STANDARD_DEVIATION 13.3 • n=5 Participants
76 mmHg
STANDARD_DEVIATION 11.5 • n=4 Participants
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q)
70.0 score on a scale
STANDARD_DEVIATION 12.0 • n=5 Participants
58.1 score on a scale
STANDARD_DEVIATION 11.1 • n=7 Participants
69.1 score on a scale
STANDARD_DEVIATION 8.3 • n=5 Participants
63.6 score on a scale
STANDARD_DEVIATION 12.6 • n=4 Participants
Cognitive and Affective Mindfulness Scale (Mindful Affect)
32.1 score on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
33.7 score on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
31.2 score on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
31.2 score on a scale
STANDARD_DEVIATION 6.6 • n=4 Participants
Perceived Stress Scale
10.5 score on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
9.7 score on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants
16.1 score on a scale
STANDARD_DEVIATION 10.1 • n=5 Participants
12 score on a scale
STANDARD_DEVIATION 8.1 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: This data point was unable to be collected, not able to complete MRIs.

functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 3 months

Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings

Outcome measures

Outcome measures
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Change in Systolic Blood Pressure
-10.4 mmHg
Standard Deviation 13.3
-3.2 mmHg
Standard Deviation 17.4
-13.8 mmHg
Standard Deviation 9.9

PRIMARY outcome

Timeframe: Baseline and 3 months

Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings

Outcome measures

Outcome measures
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Change in Diastolic Blood Pressure
-4.1 mmHg
Standard Deviation 7.9
-3.4 mmHg
Standard Deviation 8.5
-5.7 mmHg
Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change
-1.6 score on a scale
Standard Deviation 10.8
0.2 score on a scale
Standard Deviation 4.2
-6 score on a scale
Standard Deviation 9.3

SECONDARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Cognitive and Affective Mindfulness Scale Change
-3.1 score on a scale
Standard Deviation 9.1
-2.1 score on a scale
Standard Deviation 5.8
3.9 score on a scale
Standard Deviation 5.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness Plus DASH Group
n=13 Participants
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.
Education Group
n=13 Participants
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.
Control Group
n=12 Participants
Continue care as usual without intervention.
Perceived Stress Scale Change
1.2 score on a scale
Standard Deviation 4.9
0.8 score on a scale
Standard Deviation 7.4
-5.9 score on a scale
Standard Deviation 3.1

Adverse Events

Mindfulness Plus DASH Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Education Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathy Wright

The Ohio State University College of Nursing

Phone: 614-292-0309

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place