Recruiting

Observational Study

Sponsor:

University of Delaware

Code:

NCT03936582

Conditions

Physical Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Treatment

Study Details

Brief 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.

Conditions

Physical Activity

Study ID

NCT03936582

Start date

Dec 1, 2019

Status verified date

Nov, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Jun 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

All owners/managers of small businesses in 10 treatment neighborhoods will receive a request to support youth physical activity. The owners/managers will be able to direct support to specific programs, get recognized for their support, receive added information on the benefits of supporting such programs, have the oversight of an advisory board and interface with a local program representative

active comparator: control

All owners/managers of small businesses in 10 control neighborhoods will will receive a request to support youth physical activity. None of the other components of the treatment arm (e.g., direct support to specific programs, advisory board) will be provided.

Interventions

Treatment

information already included in arm/group descriptions

Primary outcome measure

  • percentages of business supporting youth physical activity programs before and after intervention [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

richard r suminski, PhD, MPH

3023392570suminski@udel.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19713

More Information

Sponsor

University of Delaware

Last update posted

Nov 3, 2020

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Delaware on 2020-11-03.