Recruiting

Infant Development

Sponsor:

University of Tennessee

Code:

NCT05878275

Conditions

Prone Position

Child Development

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

Interventions

Parent Informational Session

Study Details

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.

Conditions

Prone Position

Child Development

Study ID

NCT05878275

Start date

Nov 17, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Change in motor scale score on the Bailey Scales of Infant & Toddler Development [ Time Frame: 6 months to 48 months of age ]

Central Contacts and Locations

Central contacts

Anne H Zachry, PhD

9014963950azachry@uthsc.edu

Lauren Woods, PhD

901-268-0105lsneed@uthsc.edu

Locations

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Anne S Zachry, PhD

901-496-3950azachry@uthsc.edu

Woods H Lauren, PhD

9012680105azachry@uthsc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Mar 28, 2025

Last verified

Feb, 2025

Keywords

  • Prone Position
  • Tummy Time
  • Infant Development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2025-03-28.