- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699321
FITShop: Promoting Physical Activity in Black Barbershops (FITShop)
June 15, 2015 updated by: University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
628
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, United States, 27707
- North Carolina Central University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Materials that are provided will aim to increase a participant's minutes of physical activity.
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Other: 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.
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Materials that are provided to participants will direct them to resources for financial health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity measures
Time Frame: Baseline and 6 months
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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.
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Baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in smoking status
Time Frame: Baseline and 6 months
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Self-reported smoking status (y/n)
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Baseline and 6 months
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Change in weight/BMI
Time Frame: Baseline and 6 months
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Participants weight will be measured at baseline and 6 months.
Their BMI will be calculated
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Baseline and 6 months
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Change in waist circumference
Time Frame: Baseline and 6 months
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Participant's waist circumference will be measured at baseline and 6 months.
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Baseline and 6 months
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Change in resting heart rate
Time Frame: Baseline and 6 months
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Participant's resting heart rate will be measured at baseline and 6 months.
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Baseline and 6 months
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Change in blood pressure
Time Frame: Baseline and 6 months
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Participant's blood pressure will be measured at baseline and 6 months.
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Baseline and 6 months
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Change in aerobic fitness level
Time Frame: Baseline and 6 months
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Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.
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Baseline and 6 months
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Change in psycho-social variables
Time Frame: Baseline and 6 months
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Participant's will self-report psycho-social variables at baseline and 6 months.
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Baseline and 6 months
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Change in barber-customer interactions
Time Frame: Baseline and 6 months
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Research team will conduct shop observations at baseline and 6 months.
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Baseline and 6 months
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Change in barbershop characteristics
Time Frame: Baseline and 6 months
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Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.
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Baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 2, 2012
First Posted (Estimate)
October 3, 2012
Study Record Updates
Last Update Posted (Estimate)
June 16, 2015
Last Update Submitted That Met QC Criteria
June 15, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 10-1903
- 1U54CA156733 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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