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

November 2, 2020 updated by: Richard Suminski, University of Delaware
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: richard r suminski, PhD, MPH
  • Phone Number: 3023392570
  • Email: suminski@udel.edu

Study Contact Backup

  • Name: Shannon Robson, PhD
  • Phone Number: : 302-831-6674
  • Email: robson@udel.edu

Study Locations

    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • University of Delaware
        • Contact:
          • suminski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
information already included in arm/group descriptions
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.
information already included in arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentages of business supporting youth physical activity programs before and after intervention
Time Frame: one year
Based on baseline and post-intervention survey data as well as information tracked on the project's websites.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Youth physical activity utilization
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BHAN32214719000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Project investigators will develop policies/procedures for sharing data with other interested parties not affiliated with the original project. These policies/procedures will be defined in a data-sharing agreement. The investigators will make the data and associated documentation available to users only under the data-sharing agreement that will provide for: a commitment to using the data only for research purposes and not to identify any individual participant/community by name, a commitment to securing the data using appropriate computer technology, determining the quality of the research proposal (significance, innovativeness, approach, and community benefit), a comprehensive dissemination plan (to community and scientific audiences), sharing of administrative costs to prepare data and related documentation, appropriate approvals of research protocols by the IRB and a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

after August 2020 for a period of 10 years

IPD Sharing Access Criteria

see above

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Treatment

3
Subscribe