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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
628
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill
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Durham、North Carolina、アメリカ、27707
- North Carolina Central University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
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Materials that are provided will aim to increase a participant's minutes of physical activity.
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他の: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in physical activity measures
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in smoking status
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Laura A Linnan, ScD, CHES、University of North Carolina, Chapel Hill
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年7月1日
一次修了 (実際)
2013年9月1日
研究の完了 (実際)
2014年8月1日
試験登録日
最初に提出
2012年10月1日
QC基準を満たした最初の提出物
2012年10月2日
最初の投稿 (見積もり)
2012年10月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年6月16日
QC基準を満たした最後の更新が送信されました
2015年6月15日
最終確認日
2015年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 10-1903
- 1U54CA156733 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Your Move (physical activity)の臨床試験
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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Medisch Spectrum TwenteFoothills Medical Centre募集心血管疾患 | 生活の質 | 手術 | 運動不足 | 胸骨切開オランダ