Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings
PLAY II
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedFebruary 23, 2022
February 1, 2022
1.3 years
June 29, 2021
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Improvement on the follow-up the Physical Literacy Vital Sign (PAVSped) survey total score.
Month 6
Study Arms (2)
standard of care
NO INTERVENTIONpatient education
EXPERIMENTALThe 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)).
Interventions
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)).
Eligibility Criteria
You may qualify if:
- Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics
You may not qualify if:
- Children with physical handicaps or other significant health problems that would preclude physical activity involvement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Stracciolini, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Medical Sports Medicine; Attending, Sports Medicine Division, Department of Orthopedic Surgery; Director of Performing Arts Medicine; Principal Investigator
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 6, 2021
Study Start
August 1, 2021
Primary Completion
November 1, 2022
Study Completion
January 1, 2023
Last Updated
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
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.