Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings (PLAY II)

The proposed research will be the first study to investigate the feasibility of incorporating physical literacy screening into primary care clinical settings, while determining the efficacy of integration on physical literacy. To investigate aim 1, feasibility, the research team will provide all children ages 6-11 presenting for well-child care by the participating pediatricians with physical literacy screening (PAVSPED) at point of entry for care. The child will complete the 5 yes/no screen and answers will be provided to the pediatrician for acknowledgement. To investigate aim 2, efficacy, participants will be randomized into a control group (standard of care) or an intervention group (patient education). The intervention group will receive the patient education document with their questionnaire, randomization will occur by the study team prior to subject visits. The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)). All participants will receive a 6-month follow-up email with the same 6 questions to assess if responses changed between the two groups.

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Motility Disorder
• Intervention / Treatment: Behavioral: patient education document

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Stracciolini, MD; Phone Number: 781-216-2865; Email: andrea.stracciolini@childrens.harvard.edu
• Study Contact Backup: Name: Ben Baranker; Phone Number: 7812162865; Email: ben.baranker@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Andrea Stracciolini, MD; Phone Number: 617-355-3501; Email: andrea.stracciolini@childrens.harvard.edu
      • Contact: William Meehan, MD; Phone Number: 781-216-1328; Email: william.meehan@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics

Exclusion Criteria:

• • Children with physical handicaps or other significant health problems that would preclude physical activity involvement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard of care
EXPERIMENTAL: patient education; The intervention group will receive the patient education document with their questionnaire, randomization will occur by the study team prior to subject visits. The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)).	Behavioral: patient education document; The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Literacy Vital Sign (PAVSped) total score.	Series of yes/no questions surrounding daily moderate to vigorous physical activity. Score is the sum of all positive answers. A higher score means a better outcome, with a minimum value of 0 and maximum value of 5.	Month 2-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement on the follow-up the Physical Literacy Vital Sign (PAVSped) survey total score.	Investigators aim to assess the initial efficacy of PAVSped screening and targeted intervention on the follow-up PAVSped. The score is the sum of all positive answers. A higher score means a better outcome, with a minimum value of 0 and maximum value of 5.	Month 6

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Andrea Stracciolini, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00036957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be handled by IRB approved staff. The numerical code used to identify subjects will be kept separately in a password-protected file and will not be accessible from the rest of the database. All patient information will be stored within the Boston Children's server within a locked departmental folder. Patient data will be entered into REDCap by the patients filling out the questionnaire. No information will be kept on personal computers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No