An interventional study of Your Move (physical activity) and Your Money (financial empowerment) in Physical Activity, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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 will aim to increase a participant's minutes of physical activity.
Materials that are provided to participants will direct them to resources for financial health.
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.
Time frame: Baseline and 6 months
Change in smoking status
Self-reported smoking status (y/n)
Time frame: Baseline and 6 months
Change in weight/BMI
Participants weight will be measured at baseline and 6 months. Their BMI will be calculated
Time frame: Baseline and 6 months
Change in waist circumference
Participant's waist circumference will be measured at baseline and 6 months.
Time frame: Baseline and 6 months
Change in resting heart rate
Participant's resting heart rate will be measured at baseline and 6 months.
Time frame: Baseline and 6 months
Change in blood pressure
Participant's blood pressure will be measured at baseline and 6 months.
Time frame: Baseline and 6 months
Change in aerobic fitness level
Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.
Time frame: Baseline and 6 months
Change in psycho-social variables
Participant's will self-report psycho-social variables at baseline and 6 months.
Time frame: Baseline and 6 months
Change in barber-customer interactions
Research team will conduct shop observations at baseline and 6 months.
Time frame: Baseline and 6 months
Change in barbershop characteristics
Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.
Time frame: Baseline and 6 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill