- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01699321
FITShop: Promoting Physical Activity in Black Barbershops (FITShop)
15. juni 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
628
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Forente stater, 27707
- North Carolina Central University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in physical activity measures
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in smoking status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2012
Primær fullføring (Faktiske)
1. september 2013
Studiet fullført (Faktiske)
1. august 2014
Datoer for studieregistrering
Først innsendt
1. oktober 2012
Først innsendt som oppfylte QC-kriteriene
2. oktober 2012
Først lagt ut (Anslag)
3. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 10-1903
- 1U54CA156733 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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-
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