FITShop: Promoting Physical Activity in Black Barbershops

NCT ID: NCT01699321

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-08-31

Brief Summary

Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop research study will test the effectiveness of a program aimed at increasing physical activity among African American men. Approximately 14 barbershops and 560 shop customers within Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this research study. If FITShop is effective, we will share our results throughout North Carolina and nationally.

Detailed Description

Black men suffer disproportionately higher rates of nearly all disease categories, including cancer --the leading cause of death in North Carolina. An estimated 50% of cancer is preventable with lifestyle modifications such as increasing physical activity (PA), eliminating tobacco use/exposure and maintaining a healthy weight. Evidence suggests that physical activity can reduce risk to several types of cancer. Innovative ways to reach Black men with effective health promotion interventions are needed. Barbershops represent one place where Black men can be reached, but have not been utilized as settings for intervening to promote physical activity. An experienced, interdisciplinary, partnership between community members (barbershop owners, barbers and their customers) and researchers from UNC Chapel Hill/Lineberger Comprehensive Cancer Center and the Gillings School of Global Public Health, and North Carolina Central University are conducting a two-phase outreach study to bridge this gap. Phase 1 is a series of inter-related formative research studies (in-depth interviews with barbers/owners; observations in shops; focus groups with customers) leading to the development of a theory and evidence-guided, multi-level physical activity intervention (FITShop) designed to increase PA among Black men in barbershops. Using Phase 1 results, Phase 2 is a two-arm, group randomized, initial efficacy trial of the FITShop intervention in 14 Black barbershops with 40 customers per shop (n=560 total). Customers in Arm 1 (7 shops, 280 customers) will receive the FITShop intervention which includes barber training, PA contest in the shop, use of pedometers, community connections and personal feedback plus recommendations for PA. Customers in Arm 2 (7 shops, 280 customers) will receive a Financial Empowerment (FE) attention-control intervention that mimics exposure amount without influencing the primary outcome. Consistent with community-based participatory research principles, an Advisory Board will guide all aspects of the study planning, development, implementation and analysis of results. The primary outcome (physical activity) will be measured via accelerometer using a 7-day protocol and with self-report questionnaires at baseline and 6 months using a previously tested protocol with Black men recruited from barbershops. All primary/secondary outcomes will be measured on all customers at an assessment event/via questionnaire prior to randomization (and at 6 mo) using standardized, previously tested protocols. Process evaluation will assess dose of intervention delivered, received, fidelity, as well as reach, adoption and representativeness at the customer, barber and barbershop levels. Since barbershops are located in all communities, if effective, this intervention has promise for dissemination & sustainability.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Your Move (physical activity)

The Your Move intervention is a multi-level, theory and evidence-based intervention that will include the following components: monthly handbills with community resources, newsletters, contests (shop and customer level), tailored health feedback report, and monthly phone calls from the research team.

Group Type: EXPERIMENTAL

Your Move (physical activity)

Intervention Type: BEHAVIORAL

Materials that are provided will aim to increase a participant's minutes of physical activity.

Your Money (financial empowerment)

The Your Money program is an attention control intervention. Owners and barbers will receive 3 workshops that focus on financial health. Customers will receive monthly handbills and newsletters about different financial health topics.

Group Type: OTHER

Your Money (financial empowerment)

Intervention Type: OTHER

Materials that are provided to participants will direct them to resources for financial health.

Interventions

Your Move (physical activity)

Materials that are provided will aim to increase a participant's minutes of physical activity.

Intervention Type: BEHAVIORAL

Your Money (financial empowerment)

Materials that are provided to participants will direct them to resources for financial health.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18+ years of age
• African American
• Male
• Regular customer of the barbershop

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Central University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A Linnan, ScD, CHES

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

North Carolina Central University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1U54CA156733

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-1903

Identifier Type: -

Identifier Source: org_study_id