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Clinical Trial NCT05887583 (SPLASH) for Physical Inactivity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Tufts UniversitySupporting Physical Literacy at School and Home (SPLASH)
Clinical Trial NCT05887583 (SPLASH) is an interventional study for Physical Inactivity that is active, not recruiting. It started on 1 September 2023 with plans to enroll 400 participants. Led by Tufts University, it is expected to complete by 30 June 2026. The latest data from ClinicalTrials.gov was last updated on 26 February 2025.
Brief 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. 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.
Official Title
Supporting Physical Literacy at School and Home (SPLASH) Study
Conditions
Physical InactivityOther Study IDs
- SPLASH
- STUDY00003794
NCT ID Number
Start Date (Actual)
2023-09-01
Last Update Posted
2025-02-26
Completion Date (Estimated)
2026-06-30
Enrollment (Estimated)
400
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component. | The Rising New York Road Runners Program 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. |
No InterventionControl Standard school operating procedures | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | +/- 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. | +/- 4 weeks prior to study completion |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | +/- 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. | +/- 4 weeks prior to study completion |
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Child attends school participating in the intervention
- In the 3rd, 4th or 5th grade
- Participates in the school's physical education class
- Not in the 3rd, 4th or 5th grade
- Does not participate in the school's physical education class
Tufts University55 active trials to exploreGeorge Washington University80 active trials to exploreStudy Responsible Party
Erin Hennessy, Principal Investigator, Assistant Professor, Tufts University
No contact data.
1 Study Locations in 1 Countries
Massachusetts
Tufts University, Boston, Massachusetts, 02111, United States