Physical InactivitySPLASHNCT05887583
Supporting Physical Literacy at School and Home
A study testing The Rising New York Road Runners program in people with Physical Inactivity, run by Tufts University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test if a multilevel (school, home) physical activity intervention for school-aged (3rd-5th grade) children can increase physical activity levels. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- The Rising New York Road Runners program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 28 Feb 2026
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child attends school participating in the intervention
- In the 3rd, 4th or 5th grade
- Participates in the school's physical education class
Who cannot join
- Not in the 3rd, 4th or 5th grade
- Does not participate in the school's physical education class
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Physical Literacy at School and Home (SPLASH) Study
The goal of this clinical trial is to test if a multilevel (school, home) physical activity intervention for school-aged (3rd-5th grade) children can increase physical activity levels. The main question[s] it aims to answer are:
- The impact of the multilevel program on children's physical literacy and physical activity over one school year. Hypothesis:
- Whether the program effects are different by children's gender or weight status
- Whether changes in children's ability, confidence and motivation for physical activity are related to changes in physical activity levels.
Read more
Schools will be randomly assigned to receive the multilevel intervention or a control group.
Participants in the intervention group will receive a new school curriculum during regular physical education classes and information for families on what school activities can be done at home.
Researchers will compare outcomes according to intervention and control group assignments.
Read the detailed description
Low levels of physical activity (PA) among youth remain a significant public health problem, with most U.S. children falling short on the recommended 60 minutes of daily moderate-to-vigorous physical activity (MVPA). Research shows that this gap disproportionately affects population subgroups, particularly children who are female, overweight/obese, or from low socioeconomic areas. Interventions are needed that can equitably increase children's PA. To address this gap, there has been a focus in the U.S. and abroad on increasing children's physical literacy (PL), which can be defined as the ability, confidence, and motivation to be physically active for life. While PL-focused interventions hold promise in concept, there is little empirical evidence of effectiveness and differential effects by subgroups are not understood. Thus, the overall objective is to increase children's PA through a multilevel, comprehensive PL-focused program that will reach children both at school and at home. The overarching hypothesis is that the PL-focused program will have positive effects on elementary schoolchildren's PL and, in turn, PA.
Aims include testing the multilevel Rising New York Road Runners (RNYRR) program using a 2-arm, group randomized controlled trial (RCT) with n=400 3rd-5th grade students from low-income schools receiving either the multilevel RNYRR program (n=4) or delayed-intervention control (n=4).
Aim 3: To evaluate the impact of the RNYRR program on children's physical literacy (PL) and physical activity (PA) (total daily volume and moderate-to-vigorous PA (MVPA)) over one school year. Hypothesis: Children who attend schools with the RNYRR programming will increase PL and PA (total daily volume and MVPA) relative to children in control schools.
Aim 3a: To examine whether RNYRR program effects on children's PL and PA differ by sex or weight status.
Aim 3b: To test whether changes in PL and PL subdomains (e.g. ability, confidence, motivation) mediate changes in daily total PA volume or MVPA.
- Conditions
- Physical Inactivity
- Being tested
- The Rising New York Road Runners program
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Rising New York Road Runners programBehavioural
Also called Rising New York Road Runners
The Rising New York Road Runners program provides lesson plans covering fundamental movement skills that are intended to build competence, confidence, and motivation to be physically activity. Family engagement materials (emails, text messages, videos, social media) complement school materials to communicate what children are learning at school related to physical activity and what activities families can do at home together to reinforce these concepts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component. Receives: Behavioral: The Rising New York Road Runners program |
| Control | No intervention | Standard school operating procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline physical activity level
Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints.
Measured: +/- 4 weeks prior to study intervention
End-point physical activity level
Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints.
Measured: +/- 4 weeks prior to study completion
Secondary outcomes (2)
Baseline fundamental movement skill in running, locomotion, object control and Balance
Trained staff will administer the Physical Literacy Assessment for Youth tool to assess children's performance across 18 different tasks that assess competence in fundamental movement skill domain areas: Running, locomotion, object control and balance.
Measured: +/- 4 weeks prior to study intervention
End-point fundamental movement skill in running, locomotion, object control and Balance
Trained staff will administer the Physical Literacy Assessment for Youth tool to assess children's performance across 18 different tasks that assess competence in fundamental movement skill domain areas: Running, locomotion, object control and balance.
Measured: +/- 4 weeks prior to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Parallel groups
- Model description
- Schools will be randomized to receive either the intervention or control group condition.
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Principal investigator, Erin Hennessy, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887583
- Sponsor's protocol ID
- STUDY00003794
- Acronym
- SPLASH
- Status last verified
- Jun 2026
- First submitted
- 10 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Physical Literacy at School and Home (SPLASH) Study
- ClinicalTrials.gov ID
- NCT05887583
- Acronym / sponsor ID
- SPLASH / STUDY00003794
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 2 Jun 2023 (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.
The goal of this clinical trial is to test if a multilevel (school, home) physical activity intervention for school-aged (3rd-5th grade) children can increase physical activity levels. The main question[s] it aims to answer are:
- The impact of the multilevel program on children's physical literacy and physical activity over one school year. Hypothesis:
- Whether the program effects are different by children's gender or weight status
- Whether changes in children's ability, confidence and motivation for physical activity are related to changes in physical activity levels.
Schools will be randomly assigned to receive the multilevel intervention or a control group.
Participants in the intervention group will receive a new school curriculum during regular physical education classes and information for families on what school activities can be done at home.
Researchers will compare outcomes according to intervention and control group assignments.
Detailed description
Low levels of physical activity (PA) among youth remain a significant public health problem, with most U.S. children falling short on the recommended 60 minutes of daily moderate-to-vigorous physical activity (MVPA). Research shows that this gap disproportionately affects population subgroups, particularly children who are female, overweight/obese, or from low socioeconomic areas. Interventions are needed that can equitably increase children's PA. To address this gap, there has been a focus in the U.S. and abroad on increasing children's physical literacy (PL), which can be defined as the ability, confidence, and motivation to be physically active for life. While PL-focused interventions hold promise in concept, there is little empirical evidence of effectiveness and differential effects by subgroups are not understood. Thus, the overall objective is to increase children's PA through a multilevel, comprehensive PL-focused program that will reach children both at school and at home. The overarching hypothesis is that the PL-focused program will have positive effects on elementary schoolchildren's PL and, in turn, PA.
Aims include testing the multilevel Rising New York Road Runners (RNYRR) program using a 2-arm, group randomized controlled trial (RCT) with n=400 3rd-5th grade students from low-income schools receiving either the multilevel RNYRR program (n=4) or delayed-intervention control (n=4).
Aim 3: To evaluate the impact of the RNYRR program on children's physical literacy (PL) and physical activity (PA) (total daily volume and moderate-to-vigorous PA (MVPA)) over one school year. Hypothesis: Children who attend schools with the RNYRR programming will increase PL and PA (total daily volume and MVPA) relative to children in control schools.
Aim 3a: To examine whether RNYRR program effects on children's PL and PA differ by sex or weight status.
Aim 3b: To test whether changes in PL and PL subdomains (e.g. ability, confidence, motivation) mediate changes in daily total PA volume or MVPA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Schools will be randomized to receive either the intervention or control group condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The Rising New York Road Runners programThe Rising New York Road Runners program: A School-based physical education curriculum with family engagement component. |
| Control | No intervention | –Standard school operating procedures |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child attends school participating in the intervention
- In the 3rd, 4th or 5th grade
- Participates in the school's physical education class
Key exclusion criteria (2 listed)
- Not in the 3rd, 4th or 5th grade
- Does not participate in the school's physical education class
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 |
|---|---|---|
| The Rising New York Road Runners programAlso: Rising New York Road RunnersThe Rising New York Road Runners program provides lesson plans covering fundamental movement skills that are intended to build competence, confidence, and motivation to be physically activity. Family engagement materials (emails, text messages, videos, social media) complement school materials to communicate what children are learning at school related to physical activity and what activities families can do at home together to reinforce these concepts. | Behavioural | Intervention |
Primary outcome
Baseline physical activity level
Time frame: +/- 4 weeks prior to study intervention
Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints.
End-point physical activity level
Time frame: +/- 4 weeks prior to study completion
Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints.
2 secondary outcomes
Baseline fundamental movement skill in running, locomotion, object control and Balance
Time frame: +/- 4 weeks prior to study intervention
End-point fundamental movement skill in running, locomotion, object control and Balance
Time frame: +/- 4 weeks prior to study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided. No.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Rising New York Road Runners program in people with Physical Inactivity, run by Tufts University 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline physical activity level (time frame: +/- 4 weeks prior to study intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.