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
COMPLETED
NA
38 participants
Baseline and 3 months
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
| 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
| 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 monthsPopulation: 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 monthsOmron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
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 monthsOmron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
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 monthsDASH 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
| 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 monthsThe 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
| 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 monthsThe 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
| 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
Education Group
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place