Effectiveness of a Barbershop-Based Program to Improve High Blood Pressure Control and Awareness in Black Men

June 11, 2014 updated by: Cedars-Sinai Medical Center

Group Randomized Trial of a Barber-Based Intervention to Improve Hypertension Control in Black Men

Black men in the United States have a greater risk of developing high blood pressure than men of any other ethnic or racial group. The purpose of this study is to evaluate the effectiveness of a high blood pressure detection and medical referral program conducted by barbers in predominantly Black barbershops at increasing awareness and lowering blood pressure levels among their Black male customers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High blood pressure affects approximately 35% of Black men in the United States. This may be due to the fact that Black men frequently have an unusually high number of risk factors for high blood pressure, including diabetes, high stress levels, and increased salt intake and sensitivity. While high blood pressure can often be controlled through diet, lifestyle changes, or medication, it is a chronic asymptomatic medical condition for which individuals should remain under the care of a regular medical provider. A predominantly Black barbershop may be an optimum and receptive setting for an intervention that focuses on improving the detection and treatment of high blood pressure among Black men. In this study, barbers, deemed as influential peers, will be trained to continually monitor their customers' blood pressure, deliver health messages designed to change risk perception and ideas about healthcare utilization, and provide social support for changes in healthcare-seeking behavior and blood pressure levels. The purpose of this study is to evaluate the effectiveness of a barbershop-based intervention at increasing blood pressure awareness and lowering blood pressure levels among Black male customers. With over 18,000 Black barbershops in the United States, the results from this study may be extremely influential in improving the diagnosis and treatment of high blood pressure in Black men.

This study will enroll Black men who are regular customers at a participating barbershop. Each barbershop will be randomly assigned to either a 10-month intervention group or a control group. Nurses will train the intervention group barbers to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit. Before and after the intervention, study researchers will interview barbers and customers over an 8-week period to collect information on blood pressure control. A 12-month follow-up visit will include assessments of blood pressure levels, customer recognition of elevated blood pressure levels, and the number of customers receiving regular medical care.

Study Type

Interventional

Enrollment (Actual)

2319

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-8586
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • African American
  • Regular customer at one of the participating barbershops

Exclusion Criteria:

  • Does not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening & Enhanced Intervention
After an intensive 10-week baselne screening, the enhanced intervention group barbers will be trained to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit.
Behavioral: Baseline BP Screening
Barbers in the barbershops in the experimental arm will be trained to accurately measure and interpret blood pressure (BP). Each barber will offer a BP check to customers with each haircut, complete an encounter form after each haircut, discuss the BP reading with the customer, identify customers with elevated BP, and refer customers with elevated BP to a regular physician or other primary provider for long-term BP management. Each time a customer with elevated BP goes to a regular medical provider, he receives a free haircut, and the referring barber receives a monetary bonus.
Other: Intensive 10-week Blood Pressure Screening
Intensive 10-week Blood Pressure Screening
Active Comparator: Screening
After the intensive 10-week baseline BP screening (an intervention in itself), the barbershops in the comparison arm received a continual supply of American Heart Association pamphlets on Hypertension in African Americans.
Other: Intensive 10-week Blood Pressure Screening
Intensive 10-week Blood Pressure Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of customers with high blood pressure who achieve recommended systolic and diastolic blood pressure values
Time Frame: Measured at 12 months
Measured at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Customer recognition of elevated blood pressure levels
Time Frame: Measured at 12 months
Measured at 12 months
Number of customers with high blood pressure with a regular medical provider
Time Frame: Measured at 12 months
Measured at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
University of Texas Southwestern Medical Center
Donald W. Reynolds Foundation

Investigators

  • Principal Investigator: Ronald G. Victor, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 470
  • R01HL080582 (U.S. NIH Grant/Contract)
  • 55341
  • R01HL080582-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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