HypertensionCROWNNCT07042386
Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
A study testing CROWN Intervention in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training stylists as Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with telehealth support, community health-worker coaching, and… Read more about this study
- Who is it for?
- Ages 18 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CROWN Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women are eligible if:
- At least 18 years old
- Self-identify as Black/African American or Hispanic
- Have an average seated systolic blood pressure of 130 mmHg or higher on initial salon screening, and
- Have visited the participating salons at least twice in the past six months.
Who cannot join
- Women are excluded if:
- Pregnant or planning pregnancy during the study period
- Have end-stage renal disease requiring dialysis
- Have serious medical conditions limiting life expectancy to less than 12 months
- Currently participating in other cardiovascular intervention studies
- Have severe cognitive impairment, impeding informed consent
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- Unable to operate blood pressure monitoring equipment after training
- Plan to relocate outside the study area within 6 months
- Have documented adverse reactions to blood pressure cuff usage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Oluwabunmi Ogungbe, 410-614-1519, oogungb3@jh.edu
About this study
Official title: CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training stylists as Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with telehealth support, community health-worker coaching, and pharmacist-led medication management - among Black and Hispanic women with hypertension.
Read the detailed description
CROWN is a six-month, cluster-randomized pilot trial enrolling approximately 12 beauty salons. In intervention salons, trained Heart Health Stylists provide weekly private blood pressure screenings. Participants recruited from the intervention salons will receive a home blood pressure monitor linked to a mobile app, as well as community health worker coaching sessions and pharmacist medication support. Participants in the enhanced usual care salons will receive only printed educational materials and a home blood pressure monitor. Eligibility (age ≥18, self-identified Black or Hispanic, Systolic Blood Pressure (SBP) ≥130/80) will be confirmed via three standardized BP measurements, medical history review, and medication assessment in private salon alcoves or by phone. Assessments at baseline, 12, and 24 weeks include seated blood pressure (BP), weight, point-of-care hemoglobin A1c, and lipid panels, as well as surveys of health behaviors and social needs. Participants will receive gift cards, and retain the home monitor at the end of the study. The primary outcome is the change in systolic blood pressure; secondary outcomes include blood pressure control rates, adherence, lifestyle behaviors, and social needs resolution, with end-of-study qualitative interviews assessing acceptability.
- Conditions
- Hypertension
- Being tested
- CROWN Intervention, Enhanced Usual Care
- Keywords
- Hypertension, Implementation Science, Beauty Salon, Women, Community Based Intervention, Cardiovascular Disease Prevention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CROWN InterventionBehavioural
CROWN Intervention includes:
- Private BP screenings in salon "Heart Health Stations" by trained Heart Health Stylists
- Free Omron home BP monitor paired with a mobile app for twice-daily telemonitoring
- In-depth coaching sessions + monthly check-ins with a community health worker
- Bi-weekly medication review and adherence support by a clinical pharmacist
- Digital social-needs screening (AHC HRSN) with referral to community resources
Enhanced Usual CareBehavioural
Enhanced Usual Care include:
- Private BP screenings in salon "Heart Health Stations" by Heart Health Stylists
- Printed cardiovascular health brochures
- Free home blood pressure monitor (no app integration)
- Standard referrals to social and health services
| Study group | Role | What they receive |
|---|---|---|
| CROWN Intervention Arm | Experimental | Participants will receive in-salon blood pressure screenings by trained stylists, a home blood pressure monitor connected to a telemonitoring app, community health worker coaching, pharmacist medication support, and digital social needs screening with referrals. Receives: Behavioral: CROWN Intervention |
| Enhanced Usual Care Arm | Active comparator | Participants will receive in-salon blood pressure screenings, a free Omron home monitor, printed cardiovascular health materials, and standard referrals to social and health services, without telemonitoring, coaching, or pharmacist support. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic blood pressure
Mean change in systolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Change in Hemoglobin A1c
Hemoglobin A1c by finger-stick point of care testing (POCT)
Measured: Baseline, 3 months, 6 months
Change in weight, measured in pounds
Change in weight via calibrated scales
Measured: Baseline, 3 months, 6 months
Change in lipids level
Change in lipids level by finger-stick point of care testing (POCT)
Measured: Baseline, 3 months, 6 months
Change in Percent Body Fat
Change in percent body fat via calibrated scales
Measured: Baseline, 3 months, 6 months
Mean change in diastolic blood pressure
Mean change in diastolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start29 May 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
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 Johns Hopkins UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Oluwabunmi Ogungbe, PhD, MPH, RN, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042386
- Sponsor's protocol ID
- IRB00497859
- Other IDs
- 25ISA1453143
- Acronym
- CROWN
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
- ClinicalTrials.gov ID
- NCT07042386
- Acronym / sponsor ID
- CROWN / IRB00497859
- Conditions
- Hypertension
- Keywords
- Hypertension, Implementation Science, Beauty Salon, Women, Community Based Intervention, Cardiovascular Disease Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 29 May 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 29 Jun 2025 (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.
CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training stylists as Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with telehealth support, community health-worker coaching, and pharmacist-led medication management - among Black and Hispanic women with hypertension.
Detailed description
CROWN is a six-month, cluster-randomized pilot trial enrolling approximately 12 beauty salons. In intervention salons, trained Heart Health Stylists provide weekly private blood pressure screenings. Participants recruited from the intervention salons will receive a home blood pressure monitor linked to a mobile app, as well as community health worker coaching sessions and pharmacist medication support. Participants in the enhanced usual care salons will receive only printed educational materials and a home blood pressure monitor. Eligibility (age ≥18, self-identified Black or Hispanic, Systolic Blood Pressure (SBP) ≥130/80) will be confirmed via three standardized BP measurements, medical history review, and medication assessment in private salon alcoves or by phone. Assessments at baseline, 12, and 24 weeks include seated blood pressure (BP), weight, point-of-care hemoglobin A1c, and lipid panels, as well as surveys of health behaviors and social needs. Participants will receive gift cards, and retain the home monitor at the end of the study. The primary outcome is the change in systolic blood pressure; secondary outcomes include blood pressure control rates, adherence, lifestyle behaviors, and social needs resolution, with end-of-study qualitative interviews assessing acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CROWN Intervention Arm | Experimental | Behavioral: CROWN InterventionParticipants will receive in-salon blood pressure screenings by trained stylists, a home blood pressure monitor connected to a telemonitoring app, community health worker coaching, pharmacist medication support, and digital social needs screening with referrals. |
| Enhanced Usual Care Arm | Active comparator | Behavioral: Enhanced Usual CareParticipants will receive in-salon blood pressure screenings, a free Omron home monitor, printed cardiovascular health materials, and standard referrals to social and health services, without telemonitoring, coaching, or pharmacist support. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Self-identify as Black/African American or Hispanic
- Have an average seated systolic blood pressure of 130 mmHg or higher on initial salon screening, and
- Have visited the participating salons at least twice in the past six months.
Key exclusion criteria (9 listed)
- Pregnant or planning pregnancy during the study period
- Have end-stage renal disease requiring dialysis
- Have serious medical conditions limiting life expectancy to less than 12 months
- Currently participating in other cardiovascular intervention studies
- Have severe cognitive impairment, impeding informed consent
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 |
|---|---|---|
| CROWN InterventionCROWN Intervention includes: 1. Private BP screenings in salon "Heart Health Stations" by trained Heart Health Stylists 2. Free Omron home BP monitor paired with a mobile app for twice-daily telemonitoring 3. In-depth coaching sessions + monthly check-ins with a community health worker 4. Bi-weekly medication review and adherence support by a clinical pharmacist 5. Digital social-needs screening (AHC HRSN) with referral to community resources | Behavioural | CROWN Intervention Arm |
| Enhanced Usual CareEnhanced Usual Care include: 1. Private BP screenings in salon "Heart Health Stations" by Heart Health Stylists 2. Printed cardiovascular health brochures 3. Free home blood pressure monitor (no app integration) 4. Standard referrals to social and health services | Behavioural | Enhanced Usual Care Arm |
Primary outcome
Mean change in systolic blood pressure
Time frame: Baseline, 3 months, 6 months
Mean change in systolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
5 secondary outcomes
Change in Hemoglobin A1c
Time frame: Baseline, 3 months, 6 months
Change in weight, measured in pounds
Time frame: Baseline, 3 months, 6 months
Change in lipids level
Time frame: Baseline, 3 months, 6 months
Change in Percent Body Fat
Time frame: Baseline, 3 months, 6 months
Mean change in diastolic blood pressure
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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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.
Oluwabunmi Ogungbe, PhD, MPH, RN principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CROWN Intervention in people with Hypertension, run by Johns Hopkins University at 1 site 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwabunmi Ogungbe, PhD, MPH, RN (4106141519, oogungb3@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in systolic blood pressure (time frame: Baseline, 3 months, 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 8 Sep 2026.