FITShop: Promoting Physical Activity in Black Barbershops

Physical Activity Clinical Trial

— FITShop  

Official title:

Promoting Physical Activity in Black Barbershops

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699321
• Other study ID #: 10-1903
• Secondary ID: 1U54CA156733
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: June 15, 2015
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: August 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• African American

• Male

• Regular customer of the barbershop

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Your Move (physical activity)
Materials that are provided will aim to increase a participant's minutes of physical activity.

Other:
• Your Money (financial empowerment)
Materials that are provided to participants will direct them to resources for financial health.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	North Carolina Central University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Central University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity measures	Minutes of physical activity will be self-reported along with physical activity status, self-efficacy, barriers, etc. Accelerometers will be given at baseline and the 6 month follow-up.	Baseline and 6 months	No
Secondary	Change in smoking status	Self-reported smoking status (y/n)	Baseline and 6 months	No
Secondary	Change in weight/BMI	Participants weight will be measured at baseline and 6 months. Their BMI will be calculated	Baseline and 6 months	No
Secondary	Change in waist circumference	Participant's waist circumference will be measured at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in resting heart rate	Participant's resting heart rate will be measured at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in blood pressure	Participant's blood pressure will be measured at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in aerobic fitness level	Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in psycho-social variables	Participant's will self-report psycho-social variables at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in barber-customer interactions	Research team will conduct shop observations at baseline and 6 months.	Baseline and 6 months	No
Secondary	Change in barbershop characteristics	Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.	Baseline and 6 months	No