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Clinical Trials/NCT04950777
NCT04950777
Unknown
N/A

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

Boston Children's Hospital1 site in 1 country200 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric ALL
Sponsor
Boston Children's Hospital
Enrollment
200
Locations
1
Primary Endpoint
Physical Literacy Vital Sign (PAVSped) total score.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
January 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Stracciolini

Director, Medical Sports Medicine; Attending, Sports Medicine Division, Department of Orthopedic Surgery; Director of Performing Arts Medicine; Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Physical Literacy Vital Sign (PAVSped) total score.

Time Frame: Month 2-4

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.

Secondary Outcomes

  • Improvement on the follow-up the Physical Literacy Vital Sign (PAVSped) survey total score.(Month 6)

Study Sites (1)

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