Clinical trial NCT05887583: Supporting Physical Literacy at School and Home
Official title: Supporting Physical Literacy at School and Home (SPLASH) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: George Washington University
First posted: 2023-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be randomized to receive either the intervention or control group condition.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Child attends school participating in the intervention
* In the 3rd, 4th or 5th grade
* Participates in the school's physical education class

Exclusion Criteria:

* Not in the 3rd, 4th or 5th grade
* Does not participate in the school's physical education class

Primary outcomes:
measure: Baseline physical activity level
timeFrame: +/- 4 weeks prior to study intervention
measure: End-point physical activity level
timeFrame: +/- 4 weeks prior to study completion
Secondary outcomes:
measure: Baseline fundamental movement skill in running, locomotion, object control and Balance
timeFrame: +/- 4 weeks prior to study intervention
measure: End-point fundamental movement skill in running, locomotion, object control and Balance
timeFrame: +/- 4 weeks prior to study completion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References: