Supporting Physical Literacy at School and Home

Physical Inactivity Clinical Trial

— SPLASH  

Official title:

Supporting Physical Literacy at School and Home (SPLASH) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05887583
• Other study ID #: STUDY00003794
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: June 2026

Study information

• Verified date: August 2023
• Source: Tufts University
• Contact: Erin Hennessy, PhD
• Phone: 6176363636
• Email: erin.hennessy[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	George Washington University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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