NCT02751814

Brief Summary

Objective is to examine the physical activity and screen-time behaviors of children enrolled in licensed childcare centers before and after the enactment of new state regulations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

December 14, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

April 19, 2016

Results QC Date

July 5, 2023

Last Update Submit

March 27, 2024

Conditions

Keywords

Childcare Center RegulationsPhysical ActivitySedentary BehaviorScreen-time Behavior

Outcome Measures

Primary Outcomes (1)

  • Changes in Objective Child Physical Activity

    Physical activity will be measured with a 7 day accelerometer at baseline and 1 year, including minutes/day MVPA in childcare center, minutes/day MVPA total. Physical activity and time spent in moderate to vigorous physical activity will be measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). Children will be measured on 7 full days during the baseline and follow-up periods.The Actigraph is one of the most common accelerometers used for scientific purposes, and the GT3X+ version provides extensive data on steps/day and time spent in various activity intensities. The research team will ask the parents to have the children wear the accelerometer for additional days (to a maximum of 14 days) to ensure that minimal data requirements are met.

    1 Year

Secondary Outcomes (4)

  • Changes in Classroom Observation of Child Screen-time

    1 year

  • Parent Reports of Child Screen Time

    1 Year

  • Sedentary Behavior and Physical Activity

    1 year

  • Fundamental Motor Skills

    1 year

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Ten licensed DOE Class A or B childcare centers will be randomly selected from a list of all DOE licensed childcare centers in East Baton Rouge Parish (EBR). From the ten centers, 266 children and their parent(s) will be recruited to complete additional measures of physical activity and screen-time behaviors.

You may qualify if:

  • A child who is 3 or 4 years old
  • Child spends at least 6 hours per day, 5 days per week at a participating childcare center
  • Child will continue to attend the same childcare center for the next year

You may not qualify if:

  • Parent/legal guardian is unwilling to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (8)

  • Staiano AE, Allen AT, Fowler W, Gustat J, Kepper MM, Lewis L, Martin CK, Romain JS, Webster EK. State Licensing Regulations on Screen Time in Childcare Centers: An Impetus for Participatory Action Research. Prog Community Health Partnersh. 2018;12(1S):101-109. doi: 10.1353/cpr.2018.0025.

  • Staiano AE, Webster EK, Allen AT, Jarrell AR, Martin CK. Screen-Time Policies and Practices in Early Care and Education Centers in Relationship to Child Physical Activity. Child Obes. 2018 Aug/Sep;14(6):341-348. doi: 10.1089/chi.2018.0078.

  • Kracht CL, Webster EK, Staiano AE. A natural experiment of state-level physical activity and screen-time policy changes early childhood education (ECE) centers and child physical activity. BMC Public Health. 2020 Mar 24;20(1):387. doi: 10.1186/s12889-020-08533-8.

  • Joseph ED, Kracht CL, St Romain J, Allen AT, Barbaree C, Martin CK, Staiano AE. Young Children's Screen Time and Physical Activity: Perspectives of Parents and Early Care and Education Center Providers. Glob Pediatr Health. 2019 Jul 24;6:2333794X19865856. doi: 10.1177/2333794X19865856. eCollection 2019.

  • Webster EK, Martin CK, Staiano AE. Fundamental motor skills, screen-time, and physical activity in preschoolers. J Sport Health Sci. 2019 Mar;8(2):114-121. doi: 10.1016/j.jshs.2018.11.006. Epub 2018 Nov 24.

  • Martins, C., Webster, E. K., Bandeira, P. F. R., & Staiano, A. E. (2022). Identifying Fundamental Motor Skills Building Blocks in Preschool Children From Brazil and the United States: A Network Analysis. Journal of Motor Learning and Development, 10(1), 96-115. Retrieved Mar 27, 2024, from https://doi.org/10.1123/jmld.2021-0022

    RESULT
  • Kracht CL, Webster EK, Staiano AE. Relationship between the 24-Hour Movement Guidelines and fundamental motor skills in preschoolers. J Sci Med Sport. 2020 Dec;23(12):1185-1190. doi: 10.1016/j.jsams.2020.06.021. Epub 2020 Jul 5.

  • Kracht CL, Webster EK, Staiano AE. Sociodemographic Differences in Young Children Meeting 24-Hour Movement Guidelines. J Phys Act Health. 2019 Oct 1;16(10):908-915. doi: 10.1123/jpah.2019-0018. Epub 2019 Sep 6.

MeSH Terms

Conditions

Pediatric ObesityMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Limitations and Caveats

The timing of some assessments occurred into 2017 due to delays, there's a chance ECE centers changed their policy after the regulations were first released thus the baseline data collection was not a true baseline. However, this study did utilize handbooks for policy scoring \& baseline policies were dated for the 2016-2017 school year. Another limitation is that ECE centers were aware of the day of observation, there's a potential the center made changes to present as a healthier environment.

Results Point of Contact

Title
Dr. Amanda Staiano
Organization
LSU's Pennington Biomedical Research Center

Study Officials

  • Amanda E Staiano, PhD

    PBRC Assistant Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PBRC Assistant Professor

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 29, 2024

Results First Posted

December 14, 2023

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations