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Completed

NCT Number: NCT01699321

FITShop: Promoting Physical Activity in Black Barbershops

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Your Move (physical activity)

Behavioral

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

Your Money (financial empowerment)

Other

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

Primary outcomes

  1. Change in physical activity measures

    Time frame: Baseline and 6 months

    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 outcomes

  1. Change in smoking status

    Time frame: Baseline and 6 months

    Self-reported smoking status (y/n)

  2. Change in weight/BMI

    Time frame: Baseline and 6 months

    Participants weight will be measured at baseline and 6 months. Their BMI will be calculated

  3. Change in waist circumference

    Time frame: Baseline and 6 months

    Participant's waist circumference will be measured at baseline and 6 months.

  4. Change in resting heart rate

    Time frame: Baseline and 6 months

    Participant's resting heart rate will be measured at baseline and 6 months.

  5. Change in blood pressure

    Time frame: Baseline and 6 months

    Participant's blood pressure will be measured at baseline and 6 months.

  6. Change in aerobic fitness level

    Time frame: Baseline and 6 months

    Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.

  7. Change in psycho-social variables

    Time frame: Baseline and 6 months

    Participant's will self-report psycho-social variables at baseline and 6 months.

  8. Change in barber-customer interactions

    Time frame: Baseline and 6 months

    Research team will conduct shop observations at baseline and 6 months.

  9. Change in barbershop characteristics

    Time frame: Baseline and 6 months

    Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Central University

Registry information

Official study title

Promoting Physical Activity in Black Barbershops

Acronym: FITShop

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 3, 2012
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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