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

Boston Children's Hospital logo

Boston Children's Hospital

Status

Unknown

Conditions

Pediatric ALL
Motility Disorder

Treatments

Behavioral: patient education document

Study type

Interventional

Funder types

Other

Identifiers

NCT04950777
IRB-P00036957

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

6 to 11 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

standard of care
No Intervention group
patient education
Experimental group
Description:
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)).
Treatment:
Behavioral: patient education document

Trial contacts and locations

1

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Central trial contact

Andrea Stracciolini, MD; Ben Baranker

Data sourced from clinicaltrials.gov

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