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

NCT07042386 | Not Yet Recruiting DMC

• 2 other identifiers: IRB0049785925ISA1453143
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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 pharmacist-led medication management - among Black and Hispanic women with hypertension.

Conditions

Hypertension

Keywords

Hypertension; Implementation Science; Beauty Salon; Women; Community Based Intervention; Cardiovascular Disease Prevention

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Change in Hemoglobin A1c

  Baseline, 3 months, 6 months

• Change in weight, measured in pounds

  Baseline, 3 months, 6 months

• Change in lipids level

  Baseline, 3 months, 6 months

• Change in Percent Body Fat

  Baseline, 3 months, 6 months

• Mean change in diastolic blood pressure

  Baseline, 3 months, 6 months

Other Outcomes (9)

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

  Baseline, 3 months, 6 months

• Change in Health-related quality of life

  Baseline, 6 months

• Change in Patient activation

  Baseline, 6 months

Study Arms (2)

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.

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.

Behavioral: Enhanced Usual Care

Interventions

CROWN Intervention BEHAVIORAL

CROWN 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

CROWN Intervention Arm

Enhanced Usual Care BEHAVIORAL

Enhanced 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

Enhanced Usual Care Arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Eligibility is limited to individuals aged 18 years or older, who self-identify as women regardless of sex assigned at birth, and who self-identify as Black/African American or Hispanic.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Heart Association: collaborator
• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oluwabunmi Ogungbe, PhD, MPH, RN

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwabunmi Ogungbe, PhD, MPH, RN

CONTACT

4106141519; oogungb3@jh.edu

Yvonne Commodore-Mensah, PhD, MHS, RN

CONTACT

4106141519; ycommod1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and data analysts will be masked to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)