Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear

Not Applicable

Recruiting

• Conditions: Child Development; Prone Position
• Interventions: Behavioral: Parent Informational Session

• Registration Number: NCT05878275
• Lead Sponsor: University of Tennessee

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.

Detailed Description

The purpose of the proposed study is to examine the impact of an educational intervention on infant motor skill development. A variety of factors influence infant development, including the home environment, maternal education, child rearing practices, caregiver handling, sleep position, baby gear use, and positioning during play. In recent years there have been changes in how babies are positioned when awake. For example, after the American Academy of Pediatrics (AAP) supine sleep recommendation in 1992, some parents reported not placing their infants on the stomach for play (tummy time) while awake due to a fear of sudden infant death syndrome (SIDS). Research suggests that babies who are not exposed to enough tummy time are at risk for delays in the development of their motor skills.

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.

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Study Start: 2023-11-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Parent of the infant speaks and reads English
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. Infant is regularly cared for by an adult other than their parent for 20 hours or more per week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent Informational Session	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.

Primary Outcome Measures

Name	Time	Method
Change in motor scale score on the Bailey Scales of Infant & Toddler Development	6 months to 48 months of age	Scores range from 40 to 160, with higher scores indicating more advanced development

Secondary Outcome Measures

Name	Time	Method
Change in fine motor scale score on the Ages & Stages Questionnaire-3	6 months to 48 months of age	Scores range from 0 to 60 with higher scores indicating more advanced motor development

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States