Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
NCT ID: NCT05878275
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2023-11-17
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm
NCT03759119
Movement-based Infant Intervention
NCT03082313
Determining Optimal Dosage of Prone Positioning in Early Infancy
NCT03134859
Baby Item Learning and Development Study
NCT04267302
Development Training in Babies Born Preterm
NCT00268931
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Devices for infant positioning such as swings, bouncy seats, and carriers have also grown in popularity in recent years. More time in containers limits infant mobility and opportunities for exploration and less time in other positions for play. Many parents are not aware that varying how they handle and position their babies can positively influence development, while others have misconceptions about positioning and baby gear use.
Additional research is needed that examines the impact of avoiding screen time, limiting the use of baby gear, regularly implementing tummy time, and varying an infant's position during play. It is also important that parents are aware of the need to initiate tummy time in the first days of life to increase infant tolerance of the position. The following items will constitute as 'baby gear' and will be utilized to determine if their use impacts early motor skill development in children: infant carrier, swing, bouncy seat, or a stationary activity center. The purpose of the proposed study is to determine if an educational intervention on tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual Care Group Receiving an Informational Tummy Time Brochure
Usual care group will receive a brochure on the importance of tummy time and limiting baby gear.
No interventions assigned to this group
Parent Informational Session
Parental 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.
Parent Informational Session
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Parent Informational Session
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Individual is the parent or legal guardian of the infant.
3. Infant is 1 month of age or younger
4. Infant was carried to at least 37-weeks' gestation
5. Parent must own a cell phone will internet access and Zoom or Face Time capability
6. Parent must have a working email address.
7. Parent is over the age of 18 years
8. Family resides within a 30-min driving distance from the University of Tennessee Health Science Center,
9. Infant birthweight of at least 2500 g/ 5.5 pounds
10. Parental report of no know medical condition, health complication or problem since birth
11. that could have an impact on infant movement behaviors or development.
12. Parent reports that infant does not have a diagnosis of Gastroesophageal reflux disease (GERD).
13. Family does not expect to move from the area within 3 years of enrollment
Exclusion Criteria
1 Day
4 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tennessee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne H Zachry, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Dudek-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.
Felzer-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.
Hewitt 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.
Mendres-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.
Wen 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.
Zachry 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.
Zachry 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-09209-XP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.