Trial Outcomes & Findings for Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women (NCT NCT04266704)
NCT ID: NCT04266704
Last Updated: 2026-09-01
Results Overview
fMRI protocol - Each participant was presented the same conditions, in the same order . A fixed sequence design was used because the primary goal was to compare patterns of brain activity between participants. Means are estimated averages of each participant's response to video conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2026-09-01
Participant Flow
Participant milestones
| Measure |
Control
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
Intervention
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
subset of sample
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
Women who self-identified as African American/Black and stated they had been diagnosed with hypertension
|
Intervention
n=25 Participants
Women who self-identified as African American/Black and stated they had been diagnosed with hypertension
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.04 years
STANDARD_DEVIATION 7.60 • n=25 Participants
|
51.00 years
STANDARD_DEVIATION 8.67 • n=25 Participants
|
52.02 years
STANDARD_DEVIATION 8.13 • n=50 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Brain Activity
|
0.18 Values reflect % change in BOLD response
STANDARD_DEVIATION 0.41 • n=3 Participants • subset of sample
|
0.00 Values reflect % change in BOLD response
STANDARD_DEVIATION 0.42 • n=3 Participants • subset of sample
|
0.09 Values reflect % change in BOLD response
STANDARD_DEVIATION 0.42 • n=6 Participants • subset of sample
|
|
Systolic Blood Pressure
|
129.72 mm Hg
STANDARD_DEVIATION 13.79 • n=25 Participants
|
132.56 mm Hg
STANDARD_DEVIATION 17.41 • n=25 Participants
|
131.14 mm Hg
STANDARD_DEVIATION 15.61 • n=50 Participants
|
|
Diastolic Blood Pressure
|
86.44 mm Hg
STANDARD_DEVIATION 9.85 • n=25 Participants
|
87.08 mm Hg
STANDARD_DEVIATION 8.72 • n=25 Participants
|
86.76 mm Hg
STANDARD_DEVIATION 9.21 • n=50 Participants
|
|
PROMIS - Mental Health
|
3.16 scores on a scale
STANDARD_DEVIATION 0.69 • n=25 Participants
|
3.04 scores on a scale
STANDARD_DEVIATION 0.61 • n=25 Participants
|
3.10 scores on a scale
STANDARD_DEVIATION 0.65 • n=50 Participants
|
|
PROMIS - Physical Health
|
3.12 scores on a scale
STANDARD_DEVIATION 0.53 • n=25 Participants
|
3.24 scores on a scale
STANDARD_DEVIATION 0.44 • n=25 Participants
|
3.18 scores on a scale
STANDARD_DEVIATION 0.48 • n=50 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Due to the cost of conducting fMRI, the study was designed to evaluate brain activity in a subset of participants. At baseline, the recruitment target was met (n =10). However, due to participant drop out - the final number of fMRI scans available for analysis was n = 5.
fMRI protocol - Each participant was presented the same conditions, in the same order . A fixed sequence design was used because the primary goal was to compare patterns of brain activity between participants. Means are estimated averages of each participant's response to video conditions.
Outcome measures
| Measure |
Intervention
n=3 Participants
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
Control
n=2 Participants
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
|---|---|---|
|
Brain Activity
|
0.08 Values reflect % change in BOLD response
Standard Deviation 0.38
|
0.29 Values reflect % change in BOLD response
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participant drop out
Blood pressure was measured using automated sphygmomanometer based on standardized protocols.
Outcome measures
| Measure |
Intervention
n=13 Participants
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
Control
n=19 Participants
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
|---|---|---|
|
Systolic Blood Pressure
|
129.62 mm Hg
Standard Deviation 13.19
|
134.89 mm Hg
Standard Deviation 16.41
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participant drop out
Blood pressure was measured using automated sphygmomanometer based on standardized protocols.
Outcome measures
| Measure |
Intervention
n=13 Participants
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
Control
n=19 Participants
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
|---|---|---|
|
Diastolic Blood Pressure
|
85.31 mmHg
Standard Deviation 7.35
|
88.00 mmHg
Standard Deviation 11.30
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participant drop out
Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Intervention
n=13 Participants
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
Control
n=19 Participants
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
|---|---|---|
|
PROMIS - Mental Health
|
2.92 scores on a scale
Standard Deviation 0.64
|
3.00 scores on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participant dropout
Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Intervention
n=13 Participants
Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.
|
Control
n=19 Participants
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
|
|---|---|---|
|
PROMIS - Physical Health
|
2.92 scores on a scale
Standard Deviation 0.28
|
3.11 scores on a scale
Standard Deviation 0.32
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place