Supporting Physical Literacy at School and Home

NCT05887583 | Active Not Recruiting

• 1 other identifier: STUDY00003794
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Baseline fundamental movement skill in running, locomotion, object control and Balance

  +/- 4 weeks prior to study intervention

• End-point fundamental movement skill in running, locomotion, object control and Balance

  +/- 4 weeks prior to study completion

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: The Rising New York Road Runners program

Control

NO INTERVENTION

Standard school operating procedures

Interventions

The Rising New York Road Runners program 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.

Also known as: Rising New York Road Runners

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tufts University: lead
• George Washington University: collaborator

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Schools will be randomized to receive either the intervention or control group condition.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 2, 2023
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-01

Locations

US (1)