Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings

Pediatric ALL Clinical Trial

— PLAY II  

Official title:

Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950777
• Other study ID #: IRB-P00036957
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: January 2023

Study information

• Verified date: February 2022
• Source: Boston Children's Hospital
• Contact: Andrea Stracciolini, MD
• Phone: 781-216-2865
• Email: andrea.stracciolini[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motility Disorder
• Pediatric ALL

Intervention

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)).

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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