FITShop: Promoting Physical Activity in Black Barbershops

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
North Carolina Central University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01699321
First received: October 1, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Physical Activity
Behavioral: Your Move (physical activity)
Other: Your Money (financial empowerment)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Physical Activity in Black Barbershops

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in physical activity measures [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in smoking status [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Self-reported smoking status (y/n)

  • Change in weight/BMI [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participants weight will be measured at baseline and 6 months. Their BMI will be calculated

  • Change in waist circumference [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participant's waist circumference will be measured at baseline and 6 months.

  • Change in resting heart rate [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participant's resting heart rate will be measured at baseline and 6 months.

  • Change in blood pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participant's blood pressure will be measured at baseline and 6 months.

  • Change in aerobic fitness level [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.

  • Change in psycho-social variables [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Participant's will self-report psycho-social variables at baseline and 6 months.

  • Change in barber-customer interactions [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Research team will conduct shop observations at baseline and 6 months.

  • Change in barbershop characteristics [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.


Enrollment: 628
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Your Move (physical activity)
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.
Other: Your Money (financial empowerment)
Materials that are provided to participants will direct them to resources for financial health.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699321

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
North Carolina Central University
Durham, North Carolina, United States, 27707
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Central University
Investigators
Principal Investigator: Laura A Linnan, ScD, CHES University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01699321     History of Changes
Other Study ID Numbers: 10-1903, 1-U54-CA156733
Study First Received: October 1, 2012
Last Updated: January 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
physical activity
barbershop
cancer prevention
exercise
men's health
African American men

ClinicalTrials.gov processed this record on April 23, 2014