跳至主要内容
临床试验/NCT04950777
NCT04950777Unknown不适用

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

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Physical Literacy Vital Sign (PAVSped) total score.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics

排除标准

  • • Children with physical handicaps or other significant health problems that would preclude physical activity involvement.

结局指标

主要结局

Physical Literacy Vital Sign (PAVSped) total score.

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (2)

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