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Physical ActivityFITShopNCT01699321

FITShop: Promoting Physical Activity in Black Barbershops

A study testing Your Move (physical activity) and Your Money (financial empowerment) in people with Physical Activity, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Your Move (physical activity) and Your Money (financial empowerment)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
628 participants
Where
2 sitesUnited States
Study dates
Jul 2012to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • North Carolina Central University

    Durham, North Carolina, 27707

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Your Move (physical activity), Your Money (financial empowerment)
Keywords
physical activity, barbershop, cancer prevention, exercise, men's health, African American men
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Your Move (physical activity)Behavioural

    Materials that are provided will aim to increase a participant's minutes of physical activity.

  • Your Money (financial empowerment)Other

    Materials that are provided to participants will direct them to resources for financial health.

Study groups in NCT01699321
Study groupRoleWhat they receive
Your Move (physical activity)ExperimentalThe 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.
Receives: Behavioral: Your Move (physical activity)
Your Money (financial empowerment)OtherThe 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.
Receives: Other: Your Money (financial empowerment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity measures

    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.

    Measured: Baseline and 6 months

Secondary outcomes (9)
  1. Change in smoking status

    Self-reported smoking status (y/n)

    Measured: Baseline and 6 months

  2. Change in weight/BMI

    Participants weight will be measured at baseline and 6 months. Their BMI will be calculated

    Measured: Baseline and 6 months

  3. Change in waist circumference

    Participant's waist circumference will be measured at baseline and 6 months.

    Measured: Baseline and 6 months

  4. Change in resting heart rate

    Participant's resting heart rate will be measured at baseline and 6 months.

    Measured: Baseline and 6 months

  5. Change in blood pressure

    Participant's blood pressure will be measured at baseline and 6 months.

    Measured: Baseline and 6 months

  6. Change in aerobic fitness level

    Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.

    Measured: Baseline and 6 months

  7. Change in psycho-social variables

    Participant's will self-report psycho-social variables at baseline and 6 months.

    Measured: Baseline and 6 months

  8. Change in barber-customer interactions

    Research team will conduct shop observations at baseline and 6 months.

    Measured: Baseline and 6 months

  9. Change in barbershop characteristics

    Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699321
Sponsor's protocol ID
10-1903
Other IDs
1U54CA156733
Acronym
FITShop
Status last verified
Jun 2015
First submitted
1 Oct 2012
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Your Move (physical activity) and Your Money (financial empowerment) in people with Physical Activity, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity measures (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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