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临床试验/NCT01699321
NCT01699321已完成不适用

Promoting Physical Activity in Black Barbershops

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 628 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
628
试验地点
4
主要终点
Change in physical activity measures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Change in physical activity measures

时间窗: 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.

次要结局

  • Change in aerobic fitness level(Baseline and 6 months)
  • Change in psycho-social variables(Baseline and 6 months)
  • Change in barbershop characteristics(Baseline and 6 months)
  • Change in smoking status(Baseline and 6 months)
  • Change in weight/BMI(Baseline and 6 months)
  • Change in blood pressure(Baseline and 6 months)
  • Change in waist circumference(Baseline and 6 months)
  • Change in resting heart rate(Baseline and 6 months)
  • Change in barber-customer interactions(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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