Physical ActivityNCT03936582
Promoting Small Business Support of Youth Physical Activity in Low-income, Minority Neighborhoods
A study testing Treatment in people with Physical Activity, run by University of Delaware at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- small business (< 500 employees) in one of the 20 study areas with a physical, non-residential location.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19713
suminski
About this study
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
- Being tested
- Treatment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
information already included in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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 Receives: Behavioral: Treatment |
| control | Active comparator | 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. Receives: Behavioral: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Dec 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Suminski, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936582
- Sponsor's protocol ID
- BHAN32214719000
- Status last verified
- Nov 2020
- First submitted
- 1 May 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Suminski RR Jr, Robson S, Turner J, Plautz E. Promoting Small Business Support of Youth Physical Activity in Low-Income, Minority Neighborhoods: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 30;8(7):e13141. doi: 10.2196/13141.
PubMed 31364602
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Small Business Support of Youth Physical Activity in Low-income, Minority Neighborhoods
- ClinicalTrials.gov ID
- NCT03936582
- Acronym / sponsor ID
- BHAN32214719000
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: TreatmentAll 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 |
| control | Active comparator | Behavioral: TreatmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- small business (< 500 employees) in one of the 20 study areas with a physical, non-residential location.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatmentinformation already included in arm/group descriptions | Behavioural | Treatment, control |
Primary outcome
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.
1 secondary outcome
Youth physical activity utilization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 31364602Suminski RR Jr, Robson S, Turner J, Plautz E. Promoting Small Business Support of Youth Physical Activity in Low-Income, Minority Neighborhoods: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 30;8(7):e13141. doi: 10.2196/13141.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Physical Activity, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact richard r suminski, PhD, MPH (3023392570, suminski@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentages of business supporting youth physical activity programs before and after intervention (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.