NCT01699321

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

October 1, 2012

Last Update Submit

June 15, 2015

Conditions

Physical Activity

Keywords

physical activitybarbershopcancer preventionexercisemen's healthAfrican American men

Outcome Measures

Primary Outcomes (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.

    Baseline and 6 months

Secondary Outcomes (9)

  • Change in smoking status

    Baseline and 6 months

  • Change in weight/BMI

    Baseline and 6 months

  • Change in waist circumference

    Baseline and 6 months

  • Change in resting heart rate

    Baseline and 6 months

  • Change in blood pressure

    Baseline and 6 months

  • +4 more secondary outcomes

Study Arms (2)

Your Move (physical activity)

EXPERIMENTAL

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.

Behavioral: Your Move (physical activity)

Your Money (financial empowerment)

OTHER

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.

Other: Your Money (financial empowerment)

Interventions

Your Move (physical activity)BEHAVIORAL

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

Your Move (physical activity)
Your Money (financial empowerment)OTHER

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

Your Money (financial empowerment)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

North Carolina Central University

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura A Linnan, ScD, CHES

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

August 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

US(2)