Supporting Physical Literacy at School and Home

NCT ID: NCT05887583

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-30

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.

Conditions

Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component.

Group Type: EXPERIMENTAL

The Rising New York Road Runners program

Intervention Type: BEHAVIORAL

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.

Control

Standard school operating procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Rising New York Road Runners

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Erin Hennessy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tufts University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00003794

Identifier Type: -

Identifier Source: org_study_id