HypertensionNCT03741608
B'More for a Peaceful Motherhood Hypertension Control Study
A study testing High blood pressure management education and Home blood pressure measurement in people with Hypertension, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
This study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help African-American women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- High blood pressure management education and Home blood pressure measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jan 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypertension
- Age 18-44
- African-American
- Female
Who cannot join
- Male
- Age <18 or >44
- Non-African American
- Not female
- Pregnant
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Leonard E. Hicks Community Center
Baltimore, Maryland, 21216
Furman L. Templeton Preparatory Academy
Baltimore, Maryland, 21217
Pedestal Gardens Apartment Homes
Baltimore, Maryland, 21217
Union Baptist Harvey Johnson Head Start Program
Baltimore, Maryland, 21217
About this study
Official title: A Mindfulness and Behavioral Intervention for Reducing Hypertension Among Women of Childbearing Age
This study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help African-American women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. The investigators propose to screen women of childbearing age for hypertension, and to invite women to participate in an intervention to reduce their blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.
Read the detailed description
Chronic and pregnancy-associated hypertension increase risk for poor birth outcomes, including higher rates of low birthweight and preterm birth. Mindfulness interventions, dietary education, and smoking cessation education have all been effectively employed to reduce hypertension, but have infrequently targeted women of childbearing age in community settings. This study will screen African-American women of childbearing age for hypertension, and invite women with hypertension to participate in a seven-session intervention to reduce blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.
- Conditions
- Hypertension
- Being tested
- High blood pressure management education, Home blood pressure measurement
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High blood pressure management educationBehavioural
The 7-part education series includes 5 sessions focused on mindfulness and breathing techniques for stress reduction. One session will focus on choosing healthy, low salt foods and will provide resources for smoking cessation. The final session will include a grocery store tour to teach participants how to read food labels and to purchase healthy food.
Home blood pressure measurementBehavioural
Participants will be taught to use an automated blood pressure cuff and will be asked to provide monthly blood pressure readings to study staff.
| Study group | Role | What they receive |
|---|---|---|
| Education, BP cuff & training | Active comparator | High blood pressure management education. Home blood pressure measurement Receives: Behavioral: High blood pressure management education; Behavioral: Home blood pressure measurement |
| Education only | Active comparator | High blood pressure management education Receives: Behavioral: High blood pressure management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
decrease in systolic and diastolic blood pressure by 10 points each
Measured: 6 months
Secondary outcomes (1)
Stress
Score on Perceived Stress Scale. The Perceived Stress Scale (Cohen, S, 1994) is the most widely used psychological instrument for measuring the perception of stress. It is a 10-question survey asking to what degree certain stressors have been a problem in the past month. Responses are recorded on a 5-point Likert scale from 0 (never) to 4 (very often). The 6 negatively-stated items are scored as is, while the four positively stated items' scores are reversed. The total score may therefore range from 0 to 40. Higher scores indicate higher levels of stress (i.e. a worse outcome). There are no subscales.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start22 Jan 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: COVID prevented us from continuing recruitment and interventions at community sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will both participate in the 7-part educational series to reduce high blood pressure. One of the two groups will also be given a blood pressure cuff and will be trained to check their own blood pressure. We will track blood pressure and stress level of both groups for 6 months
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Lane, University of Maryland, Baltimore
- Investigators
- Wendy G Lane, MD, MPH, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741608
- Sponsor's protocol ID
- HP-00082822
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2018
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share blood pressure measurements and Perceived Stress Scale measurements upon request
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness and Behavioral Intervention for Reducing Hypertension Among Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT03741608
- Acronym / sponsor ID
- HP-00082822
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID prevented us from continuing recruitment and interventions at community sites
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help African-American women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. The investigators propose to screen women of childbearing age for hypertension, and to invite women to participate in an intervention to reduce their blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.
Detailed description
Chronic and pregnancy-associated hypertension increase risk for poor birth outcomes, including higher rates of low birthweight and preterm birth. Mindfulness interventions, dietary education, and smoking cessation education have all been effectively employed to reduce hypertension, but have infrequently targeted women of childbearing age in community settings. This study will screen African-American women of childbearing age for hypertension, and invite women with hypertension to participate in a seven-session intervention to reduce blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will both participate in the 7-part educational series to reduce high blood pressure. One of the two groups will also be given a blood pressure cuff and will be trained to check their own blood pressure. We will track blood pressure and stress level of both groups for 6 months
| Arm | Type | Receives |
|---|---|---|
| Education, BP cuff & training | Active comparator | Behavioral: High blood pressure management education, Behavioral: Home blood pressure measurementHigh blood pressure management education. Home blood pressure measurement |
| Education only | Active comparator | Behavioral: High blood pressure management educationHigh blood pressure management education |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hypertension
- Age 18-44
- African-American
- Female
Key exclusion criteria (5 listed)
- Male
- Age <18 or >44
- Non-African American
- Not female
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High blood pressure management educationThe 7-part education series includes 5 sessions focused on mindfulness and breathing techniques for stress reduction. One session will focus on choosing healthy, low salt foods and will provide resources for smoking cessation. The final session will include a grocery store tour to teach participants how to read food labels and to purchase healthy food. | Behavioural | Education only, Education, BP cuff & training |
| Home blood pressure measurementParticipants will be taught to use an automated blood pressure cuff and will be asked to provide monthly blood pressure readings to study staff. | Behavioural | Education, BP cuff & training |
Primary outcome
Blood pressure reduction
Time frame: 6 months
decrease in systolic and diastolic blood pressure by 10 points each
1 secondary outcome
Stress
Time frame: 6 months
Results and safety
The study was stopped early (reason given: COVID prevented us from continuing recruitment and interventions at community sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No. We will share blood pressure measurements and Perceived Stress Scale measurements upon request
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy G Lane, MD, MPH principal investigator
University of Maryland, College Park
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High blood pressure management education and Home blood pressure measurement in people with Hypertension, run by University of Maryland, Baltimore at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID prevented us from continuing recruitment and interventions at community sites). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.