- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936582
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
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.
Sponsor
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.
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