Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development
1 other identifier
interventional
50
1 country
1
Brief Summary
The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development. The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 28, 2025
February 1, 2025
4.1 years
March 22, 2023
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in motor scale score on the Bailey Scales of Infant & Toddler Development
Scores range from 40 to 160, with higher scores indicating more advanced development
6 months to 48 months of age
Secondary Outcomes (1)
Change in fine motor scale score on the Ages & Stages Questionnaire-3
6 months to 48 months of age
Study Arms (2)
Usual Care Group Receiving an Informational Tummy Time Brochure
NO INTERVENTIONUsual care group will receive a brochure on the importance of tummy time and limiting baby gear.
Parent Informational Session
EXPERIMENTALParental education session that includes information and a video on avoiding screen time in the first two years of life, the importance and benefits of infants being exposed to tummy time, varying play positions and limiting time in baby gear. Additional information will be provided on the importance of implementing tummy time during the first month of life as well as different ways to implement tummy time and how to increase infant tolerance to tummy time. Parents in the Parent Informational Session can request a Zoom consultation with the Principal Investigator if the parents have questions or need guidance with implementing tummy time.
Interventions
Parents will receive a brochure on the importance of tummy time and limiting baby gear and watch a video on the importance of tummy time and limiting baby gear and receive support for implementing tummy time if requested.
Eligibility Criteria
You may qualify if:
- Parent of the infant speaks and reads English
- Individual is the parent or legal guardian of the infant.
- Infant is 1 month of age or younger
- Infant was carried to at least 37-weeks' gestation
- Parent must own a cell phone will internet access and Zoom or Face Time capability
- Parent must have a working email address.
- Parent is over the age of 18 years
- Family resides within a 30-min driving distance from the University of Tennessee Health Science Center,
- Infant birthweight of at least 2500 g/ 5.5 pounds
- Parental report of no know medical condition, health complication or problem since birth
- that could have an impact on infant movement behaviors or development.
- Parent reports that infant does not have a diagnosis of Gastroesophageal reflux disease (GERD).
- Family does not expect to move from the area within 3 years of enrollment
You may not qualify if:
- \. Infant is regularly cared for by an adult other than their parent for 20 hours or more per week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Related Publications (8)
De Bock F, Braun V, Renz-Polster H. Deformational plagiocephaly in normal infants: a systematic review of causes and hypotheses. Arch Dis Child. 2017 Jun;102(6):535-542. doi: 10.1136/archdischild-2016-312018. Epub 2017 Jan 19.
PMID: 28104626RESULTDudek-Shriber L, Zelazny S. The effects of prone positioning on the quality and acquisition of developmental milestones in four-month-old infants. Pediatr Phys Ther. 2007 Spring;19(1):48-55. doi: 10.1097/01.pep.0000234963.72945.b1.
PMID: 17304097RESULTFelzer-Kim IT, Erickson K, Adkins C, Hauck JL. Wakeful Prone "Tummy Time" During Infancy: How Can We Help Parents? Phys Occup Ther Pediatr. 2020;40(6):651-668. doi: 10.1080/01942638.2020.1742847. Epub 2020 Mar 19.
PMID: 32192403RESULTHewitt L, Kerr E, Stanley RM, Okely AD. Tummy Time and Infant Health Outcomes: A Systematic Review. Pediatrics. 2020 Jun;145(6):e20192168. doi: 10.1542/peds.2019-2168. Epub 2020 May 5.
PMID: 32371428RESULTMendres-Smith AE, Borrero JC, Castillo MI, Davis BJ, Becraft JL, Hussey-Gardner B. Tummy time without the tears: The impact of parent positioning and play. J Appl Behav Anal. 2020 Sep;53(4):2090-2107. doi: 10.1002/jaba.715. Epub 2020 May 20.
PMID: 32436294RESULTWen LM, Baur LA, Simpson JM, Rissel C, Flood VM. Effectiveness of an early intervention on infant feeding practices and "tummy time": a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Aug;165(8):701-7. doi: 10.1001/archpediatrics.2011.115.
PMID: 21810633RESULTZachry AH, Kitzmann KM. Caregiver awareness of prone play recommendations. Am J Occup Ther. 2011 Jan-Feb;65(1):101-5. doi: 10.5014/ajot.2011.09100.
PMID: 21309377RESULTZachry AH, Nolan VG, Hand SB, Klemm SA. Infant Positioning, Baby Gear Use, and Cranial Asymmetry. Matern Child Health J. 2017 Dec;21(12):2229-2236. doi: 10.1007/s10995-017-2344-6.
PMID: 28725930RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Anne H Zachry, PhD
University of Tennessee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Single Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
May 26, 2023
Study Start
November 17, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Supporting data will be available upon the acceptance of the research paper. The data will be available for 6 years.
- Access Criteria
- "Access to data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
The investigators are working on a plan to make individual participant data (IPD) available to other researchers.