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FITShop: Promoting Physical Activity in Black Barbershops (FITShop)

2015年6月15日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

628

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina At Chapel Hill
      • Durham、North Carolina、美国、27707
        • North Carolina Central University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

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

Exclusion Criteria:

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
其他: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in physical activity measures
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in smoking status
大体时间:Baseline and 6 months
Self-reported smoking status (y/n)
Baseline and 6 months
Change in weight/BMI
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Baseline and 6 months
Research team will conduct shop observations at baseline and 6 months.
Baseline and 6 months
Change in barbershop characteristics
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Laura A Linnan, ScD, CHES、University of North Carolina, Chapel Hill

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2012年10月1日

首先提交符合 QC 标准的

2012年10月2日

首次发布 (估计)

2012年10月3日

研究记录更新

最后更新发布 (估计)

2015年6月16日

上次提交的符合 QC 标准的更新

2015年6月15日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 10-1903
  • 1U54CA156733 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Your Move (physical activity)的临床试验

3
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