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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04950777
Acronym
PLAY II
Enrollment
200
Registered
2021-07-06
Start date
2021-08-01
Completion date
2023-01-31
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motility Disorder, Pediatric ALL

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.

Interventions

BEHAVIORALpatient 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)).

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical Literacy Vital Sign (PAVSped) total score.Month 2-4Series 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

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

Countries

United States

Contacts

Primary ContactAndrea Stracciolini, MD
andrea.stracciolini@childrens.harvard.edu781-216-2865
Backup ContactBen Baranker
ben.baranker@childrens.harvard.edu7812162865

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026