- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01699321
FITShop: Promoting Physical Activity in Black Barbershops (FITShop)
15 juni 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
628
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Förenta staterna, 27707
- North Carolina Central University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- 18+ years of age
- African American
- Male
- Regular customer of the barbershop
Exclusion Criteria:
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in physical activity measures
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in smoking status
Tidsram: Baseline and 6 months
|
Self-reported smoking status (y/n)
|
Baseline and 6 months
|
|
Change in weight/BMI
Tidsram: 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
Tidsram: Baseline and 6 months
|
Participant's waist circumference will be measured at baseline and 6 months.
|
Baseline and 6 months
|
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Change in resting heart rate
Tidsram: Baseline and 6 months
|
Participant's resting heart rate will be measured at baseline and 6 months.
|
Baseline and 6 months
|
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Change in blood pressure
Tidsram: 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
Tidsram: 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
|
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Change in psycho-social variables
Tidsram: Baseline and 6 months
|
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
Tidsram: Baseline and 6 months
|
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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Laura A Linnan, ScD, CHES, University of North Carolina, Chapel Hill
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 september 2013
Avslutad studie (Faktisk)
1 augusti 2014
Studieregistreringsdatum
Först inskickad
1 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
2 oktober 2012
Första postat (Uppskatta)
3 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2015
Senast verifierad
1 juni 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 10-1903
- 1U54CA156733 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .