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FITShop: Promoting Physical Activity in Black Barbershops (FITShop)

15. juni 2015 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

628

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina At Chapel Hill
      • Durham, North Carolina, Forenede Stater, 27707
        • North Carolina Central University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in physical activity measures
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in smoking status
Tidsramme: Baseline and 6 months
Self-reported smoking status (y/n)
Baseline and 6 months
Change in weight/BMI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 6 months
Research team will conduct shop observations at baseline and 6 months.
Baseline and 6 months
Change in barbershop characteristics
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

1. oktober 2012

Først indsendt, der opfyldte QC-kriterier

2. oktober 2012

Først opslået (Skøn)

3. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 10-1903
  • 1U54CA156733 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med Your Move (physical activity)

3
Abonner