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

NCT ID: NCT04950777

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-01-31

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.

Conditions

Pediatric ALL; Motility Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this 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)).

Group Type: EXPERIMENTAL

patient education document

Intervention Type: BEHAVIORAL

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

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)).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrea Stracciolini

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Stracciolini, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Stracciolini, MD

Role: CONTACT

andrea.stracciolini@childrens.harvard.edu

781-216-2865

Ben Baranker

Role: CONTACT

ben.baranker@childrens.harvard.edu

7812162865

Facility Contacts

Andrea Stracciolini, MD

Role: primary

andrea.stracciolini@childrens.harvard.edu

617-355-3501

William Meehan, MD

Role: backup

william.meehan@childrens.harvard.edu

781-216-1328

Other Identifiers

IRB-P00036957

Identifier Type: -

Identifier Source: org_study_id