- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01699321
FITShop: Promoting Physical Activity in Black Barbershops (FITShop)
15 juin 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
628
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina At Chapel Hill
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Durham, North Carolina, États-Unis, 27707
- North Carolina Central University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in physical activity measures
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in smoking status
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2012
Achèvement primaire (Réel)
1 septembre 2013
Achèvement de l'étude (Réel)
1 août 2014
Dates d'inscription aux études
Première soumission
1 octobre 2012
Première soumission répondant aux critères de contrôle qualité
2 octobre 2012
Première publication (Estimation)
3 octobre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 juin 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2015
Dernière vérification
1 juin 2015
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 10-1903
- 1U54CA156733 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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