Pediatric ALLPLAY IINCT04950777
Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings
A study testing patient education document in people with Pediatric ALL and Motility Disorder, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Motility Disorder
- What is being tested?
- patient education document
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics
Who cannot join
- • Children with physical handicaps or other significant health problems that would preclude physical activity involvement.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Andrea Stracciolini, MD, 617-355-3501, andrea.stracciolini@childrens.harvard.edu
William Meehan, MD, 781-216-1328, william.meehan@childrens.harvard.edu
About this study
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
- Being tested
- patient education document
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education documentBehavioural
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)).
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Not described |
| patient education | Experimental | 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)). Receives: Behavioral: patient education document |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2-4
Secondary outcomes (1)
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Aug 2021
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Stracciolini, Boston Children's Hospital
- Investigators
- Andrea Stracciolini, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950777
- Sponsor's protocol ID
- IRB-P00036957
- Acronym
- PLAY II
- Status last verified
- Feb 2022
- First submitted
- 29 Jun 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be handled by IRB approved staff. The numerical code used to identify subjects will be kept separately in a password-protected file and will not be accessible from the rest of the database. All patient information will be stored within the Boston Children's server within a locked departmental folder. Patient data will be entered into REDCap by the patients filling out the questionnaire. No information will be kept on personal computers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings
- ClinicalTrials.gov ID
- NCT04950777
- Acronym / sponsor ID
- PLAY II / IRB-P00036957
- Conditions
- Pediatric ALL, Motility Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | – |
| patient education | Experimental | Behavioral: patient education documentThe 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)). |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics
Key exclusion criteria (1 listed)
- • Children with physical handicaps or other significant health problems that would preclude physical activity involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient education documentThe 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)). | Behavioural | patient education |
Primary outcome
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.
1 secondary outcome
Improvement on the follow-up the Physical Literacy Vital Sign (PAVSped) survey total score.
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No. All data will be handled by IRB approved staff. The numerical code used to identify subjects will be kept separately in a password-protected file and will not be accessible from the rest of the database. All patient information will be stored within the Boston Children's server within a locked departmental folder. Patient data will be entered into REDCap by the patients filling out the questionnaire. No information will be kept on personal computers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Stracciolini, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient education document in people with Pediatric ALL and Motility Disorder, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Stracciolini, MD (781-216-2865, andrea.stracciolini@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Literacy Vital Sign (PAVSped) total score. (time frame: Month 2-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.