Clinical trial NCT01699321: FITShop: Promoting Physical Activity in Black Barbershops
Official title: Promoting Physical Activity in Black Barbershops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
barbershop
cancer prevention
exercise
men's health
African American men
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Central University
First posted: 2012-10-03
Enrollment: 628
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Change in physical activity measures
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in smoking status
timeFrame: Baseline and 6 months
measure: Change in weight/BMI
timeFrame: Baseline and 6 months
measure: Change in waist circumference
timeFrame: Baseline and 6 months
measure: Change in resting heart rate
timeFrame: Baseline and 6 months
measure: Change in blood pressure
timeFrame: Baseline and 6 months
measure: Change in aerobic fitness level
timeFrame: Baseline and 6 months
measure: Change in psycho-social variables
timeFrame: Baseline and 6 months
measure: Change in barber-customer interactions
timeFrame: Baseline and 6 months
measure: Change in barbershop characteristics
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: North Carolina Central University
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura A Linnan, ScD, CHES
role: PRINCIPAL_INVESTIGATOR
References: