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FITShop: Promoting Physical Activity in Black Barbershops (FITShop)
15 juni 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
628
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Verenigde Staten, 27707
- North Carolina Central University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Ander: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in physical activity measures
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in smoking status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2012
Primaire voltooiing (Werkelijk)
1 september 2013
Studie voltooiing (Werkelijk)
1 augustus 2014
Studieregistratiedata
Eerst ingediend
1 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
2 oktober 2012
Eerst geplaatst (Schatting)
3 oktober 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
16 juni 2015
Laatste update ingediend die voldeed aan QC-criteria
15 juni 2015
Laatst geverifieerd
1 juni 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 10-1903
- 1U54CA156733 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Your Move (physical activity)
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)WervingFysieke activiteit | Insuline-resistentie | Puberteit | PCOS (polycysteus ovariumsyndroom)Verenigde Staten
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Ming-Yuan ChihVoltooid
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University of California, San FranciscoVoltooidDarmkanker | EndeldarmkankerVerenigde Staten
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Penn State UniversityNog niet aan het wervenCardiovasculair (CV) risicoVerenigde Staten
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University of Alabama at BirminghamNational Cancer Institute (NCI)Werving
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The University of Hong KongWervingDementie | Last van mantelzorgers | Cognitieve stoornis, mild | Dementie, mildHongkong
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The Miriam HospitalOnbekendHartinfarct | Sedentaire levensstijl | Ischemische aanval, voorbijgaand | OefeningVerenigde Staten
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Cairo UniversityAanmelden op uitnodiging
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Istituto Ortopedico RizzoliUniversity of BolognaVoltooidVerbeter de levenskwaliteitItalië