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FITShop: Promoting Physical Activity in Black Barbershops (FITShop)

15 de junio de 2015 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

628

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, Estados Unidos, 27707
        • North Carolina Central University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Materials that are provided will aim to increase a participant's minutes of physical activity.
Otro: 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.
Materials that are provided to participants will direct them to resources for financial health.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in physical activity measures
Periodo de tiempo: 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.
Baseline and 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in smoking status
Periodo de tiempo: Baseline and 6 months
Self-reported smoking status (y/n)
Baseline and 6 months
Change in weight/BMI
Periodo de tiempo: Baseline and 6 months
Participants weight will be measured at baseline and 6 months. Their BMI will be calculated
Baseline and 6 months
Change in waist circumference
Periodo de tiempo: Baseline and 6 months
Participant's waist circumference will be measured at baseline and 6 months.
Baseline and 6 months
Change in resting heart rate
Periodo de tiempo: Baseline and 6 months
Participant's resting heart rate will be measured at baseline and 6 months.
Baseline and 6 months
Change in blood pressure
Periodo de tiempo: Baseline and 6 months
Participant's blood pressure will be measured at baseline and 6 months.
Baseline and 6 months
Change in aerobic fitness level
Periodo de tiempo: Baseline and 6 months
Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.
Baseline and 6 months
Change in psycho-social variables
Periodo de tiempo: Baseline and 6 months
Participant's will self-report psycho-social variables at baseline and 6 months.
Baseline and 6 months
Change in barber-customer interactions
Periodo de tiempo: Baseline and 6 months
Research team will conduct shop observations at baseline and 6 months.
Baseline and 6 months
Change in barbershop characteristics
Periodo de tiempo: Baseline and 6 months
Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.
Baseline and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2012

Finalización primaria (Actual)

1 de septiembre de 2013

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2012

Primero enviado que cumplió con los criterios de control de calidad

2 de octubre de 2012

Publicado por primera vez (Estimar)

3 de octubre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de junio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2015

Última verificación

1 de junio de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 10-1903
  • 1U54CA156733 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Your Move (physical activity)

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