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NCT Number: NCT07042386

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.

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Key information

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Oluwabunmi Ogungbe

CONTACT

[email protected]

410-614-1519

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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
  • 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.

Treatment and study plan

CROWN Intervention

Behavioral

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 Care

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: Baseline, 3 months, 6 months

    Hemoglobin A1c by finger-stick point of care testing (POCT)

  2. Change in weight, measured in pounds

    Time frame: Baseline, 3 months, 6 months

    Change in weight via calibrated scales

  3. Change in lipids level

    Time frame: Baseline, 3 months, 6 months

    Change in lipids level by finger-stick point of care testing (POCT)

  4. Change in Percent Body Fat

    Time frame: Baseline, 3 months, 6 months

    Change in percent body fat via calibrated scales

  5. Mean change in diastolic blood pressure

    Time frame: Baseline, 3 months, 6 months

    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).

Other outcomes

  1. Change in Number of times health-related social resources were accessed

    Time frame: Baseline, 3 months, 6 months

    Social resource utilization assessed by the AHC Health-Related Social Needs (HRSN) digital screening tool

  2. Change in Health-related quality of life

    Time frame: Baseline, 6 months

    Measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 instrument. Score ranges from 4-20, where a higher score correlates to better outcome.

  3. Change in Patient activation

    Time frame: Baseline, 6 months

    Assessed via the Patient Activation Measure-13 (PAM-13). Score of 0-100 where higher scores indicate a better outcome

  4. Change in Medication adherence

    Time frame: Baseline, 6 months

    Measured with the Hill-Bone Medication Adherence Scale. The total score ranges from 14 to 56. 14 is the worse adherence and 56 is the best adherence.

  5. Change in Self-efficacy

    Time frame: Baseline, 6 months

    Assessed using the New Self-Efficacy Scale (Score Range: 1-5; Higher scores are better)

  6. Implementation fidelity

    Time frame: 6 months

    Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of salons that completed the study.

  7. Implementation fidelity

    Time frame: 6 months

    Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of deviations per salon.

  8. Adoption

    Time frame: 6 months

    Adoption will be measured by the proportion of invited salons and stylists who engage with the intervention.

  9. Program Cost effectiveness

    Time frame: 6 months

    Program costs, including expenses for stylist training, salon support, Community Health Worker (CHW) time, and technology infrastructure, will be tracked. Incremental Cost-Effectivness Ratio be reported. The ratio is the additional cost of one intervention compared to another, divided by the difference in their health outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Oluwabunmi Ogungbe, PhD, MPH, RN

CONTACT

[email protected]

4106141519

Yvonne Commodore-Mensah, PhD, MHS, RN

CONTACT

[email protected]

4106141519

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women

Acronym: CROWN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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