Promoting Small Business Support of Youth Physical Activity in Low-income, Minority Neighborhoods

Physical Activity Clinical Trial

Official title:

Promoting Small Business Support of Youth Physical Activity in Low-income, Minority Neighborhoods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936582
• Other study ID #: BHAN32214719000
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2020
• Source: University of Delaware
• Contact: richard r suminski, PhD, MPH
• Phone: 3023392570
• Email: suminski[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An unacceptably high percentage of our nation's low-income, minority youth (< 18 years of age) are not regularly physically active. This contributes to extreme health disparities such as obesity rates nearly two-fold higher than those seen in white youth and greater risk for diabetes and related cardiometabolic disorders. The presence of quality youth physical activity opportunities (YPAO) enables and encourages physically active lifestyles. Unfortunately, quality YPAOs often are lacking in places where minority youth live, resulting in low activity levels and subsequent health issues that represent significant disparities in our society. The investigators' previous research found that small businesses (< 500 employees), which represent over 99% of all employers, are powerful resources for creating and improving YPAOs. In accordance with the Socioecological Model and established philanthropic principles, the investigators developed an alpha version of an intervention (alpha-i) for increasing small businesses' involvement with YPAOs. The investigators are now poised to create a beta version (beta-i) and conduct a pilot study of its impact on small business support for YPAOs and YPAO utilization by youth in low-income, minority neighborhoods. To meet this objective, the investigators will complete the following specific aims. Aim 1: Refine alpha-i components by completing focus groups with small business owners, YPAO providers, and parents/guardians of youth from low-income, predominantly minority neighborhoods. Results of the qualitative analysis will inform final tailoring of the intervention to create the beta-i which will be tested in Aim 2. Aim 2: Determine the effect of the beta-i on small business support for YPAOs in low-income, minority neighborhoods by conducting a plot cluster randomized-control trial with randomization at the neighborhood level. Intervention neighborhoods (n=10) will receive the beta-i while control neighborhoods (n=10) will be provided a standard practice intervention for a period of one year. The primary outcome for aim 2 will be the percentage of small businesses not supporting YPAOs at baseline that subsequently provide support for YPAOs at follow-up. The investigators also will consider the U.S. dollar equivalent of all types of support (monetary, goods/services and time) donated for YPAOs by small businesses. Aim 3: Examine the impact of the increased small business support for YPAOs on YPAO utilization by youth. The primary outcome will be the percent change in the number of youth participating in YPAOs from baseline and follow-up in the treatment and control neighborhoods. The proposed study is significant because it will provide evidence that an easily replicated approach can be used to increase small business support for YPAOs and that this support results in greater use of the YPAOs by youth. The investigators' next step will be to determine if YPAO changes resulting from increased small business support positively influence youth physical activity levels as measured by accelerometry. The investigators long-term goals are to create a nationally implementable practice for increasing support for YPAOs and strengthen the science of addressing health disparities in socially disadvantaged populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• small business (< 500 employees) in one of the 20 study areas with a physical, non-residential location.

Exclusion Criteria:

• large businesses (500 or more employees) not in one of the 20 study areas, does not have a physical location or the physical location is residential.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Treatment
information already included in arm/group descriptions

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentages of business supporting youth physical activity programs before and after intervention	Based on baseline and post-intervention survey data as well as information tracked on the project's websites.	one year
Secondary	Youth physical activity utilization	Percent change in the number of youth participating in youth activity programs from baseline and follow-up in the treatment and control neighborhoods	one year