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

Not Applicable

Not yet recruiting

• Conditions: Hypertension

• Registration Number: NCT07042386
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-15
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in systolic blood pressure	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 Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	Baseline, 3 months, 6 months	Hemoglobin A1c by finger-stick point of care testing (POCT)
Change in weight, measured in pounds	Baseline, 3 months, 6 months	Change in weight via calibrated scales
Change in lipids level	Baseline, 3 months, 6 months	Change in lipids level by finger-stick point of care testing (POCT)
Change in Percent Body Fat	Baseline, 3 months, 6 months	Change in percent body fat via calibrated scales
Mean change in diastolic blood pressure	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).

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States