Childhood ObesityPause and PlayNCT02751788

Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations. Read more about this study

Who is it for?: Ages 3 to 4 yearsHealthy volunteers can take part
Conditions the study is for: Childhood Obesity
How many people: 112 participants
Where: 1 siteUnited States
Study dates: Apr 2016to 1 Jun 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 4 years
All sexes
Healthy volunteers accepted
Child

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)

Who may be able to join

Licensed by DOE as a Class A or Class B childcare center
Located in East Baton Rouge Parish
Current childcare enrollment of at least 18 children between the ages of 3-4 years

Who cannot join

Childcare center and/or childcare center director unwilling to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 1

The goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations.

Read the detailed description

Pause and Play will take a prospective observational epidemiological approach before and after enactment of new regulations. 10 childcare centers licensed in East Baton Rouge Parish will be randomly selected and standardized behavioral observation scales will be used to objectively quantify the physical activity and screen-time environment of the centers and the children's behaviors both in and outside the center. These assessments will be collected twice during the 2-year grant period to capture potential changes after the policies are implemented.

Conditions: Childhood Obesity
Keywords: childcare center regulations, physical activity, sedentary behavior, screen-time behavior
Medical subject headings: Pediatric Obesity, Motor Activity, Sedentary Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
The EPAO instrument will be used, which is a comprehensive, day-long observation that objectively defines the nutrition and physical activity environmental characteristics of child care centers. To address the specific aim, only the EPAO variables related to physical activity and screen-time will be included in the assessment. Means, standard deviations, and Pearson correlations will be calculated to describe the sample and examine relationships among the environment subscales at baseline and follow-up. Differences in center characteristics (i.e. racial distribution) will be tested using t-tests and chi-square tests. Repeated measures analysis of covariance (ANCOVAs) will be used to examine change in the EPAO score overall. Higher scores indicate higher compliance with best practices.
Measured: 1 year

Secondary outcomes (1)

Changes in Practice-based Survey Items Based on Childcare Director Responses.
A survey will be administered to the director of each childcare center to determine the following: awareness of the new policy; structured programs and/or field trips that allow children to be physically active (including number of times per day or week); if one or more community organizations support or provide physical activity programs at the center; whether or not the childcare center has policies regarding television viewing and computer use; amount of time allowed for free play; and amount of time spent outside.
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20161 Jun 2018

First posted26 Apr 2016 (estimated)
Study startApr 2016
Primary completion1 Jun 2018
Study completion1 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Childhood ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02751788
Sponsor's protocol ID: PBRC 2015-044
Acronym: Pause and Play
Status last verified: Mar 2024
First submitted: 19 Apr 2016
Last updated: 29 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 32209069
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.
PubMed 30199286
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.
PubMed 29755053
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.
PubMed 31384633
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.
PubMed 30997257
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
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.
PubMed 32653249
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.
PubMed 31491748
Webster EK, Spring KE, Moore JX, Brandon D, Staiano AE. Diverging Paths: Longitudinal and Reciprocal Associations Between Two Fundamental Motor Skill Assessments in Preschoolers. Child Care Health Dev. 2026 May;52(3):e70295. doi: 10.1111/cch.70295.
PubMed 42151099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 1
ClinicalTrials.gov ID: NCT02751788
Acronym / sponsor ID: Pause and Play / PBRC 2015-044
Conditions: Childhood Obesity
Keywords: childcare center regulations, physical activity, sedentary behavior, screen-time behavior
Study type: Observational
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: Apr 2016 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 26 Apr 2016 (estimated)
Results: Posted 7 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 3 to 4 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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)

Key inclusion criteria (3 listed)

Licensed by DOE as a Class A or Class B childcare center
Located in East Baton Rouge Parish
Current childcare enrollment of at least 18 children between the ages of 3-4 years

Key exclusion criteria (1 listed)

Childcare center and/or childcare center director unwilling to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
Time frame: 1 year
The EPAO instrument will be used, which is a comprehensive, day-long observation that objectively defines the nutrition and physical activity environmental characteristics of child care centers. To address the specific aim, only the EPAO variables related to physical activity and screen-time will be included in the assessment. Means, standard deviations, and Pearson correlations will be calculated to describe the sample and examine relationships among the environment subscales at baseline and follow-up. Differences in center characteristics (i.e. racial distribution) will be tested using t-tests and chi-square tests. Repeated measures analysis of covariance (ANCOVAs) will be used to examine change in the EPAO score overall. Higher scores indicate higher compliance with best practices.

1 secondary outcome

Changes in Practice-based Survey Items Based on Childcare Director Responses.
Time frame: 1 Year

Results and safety

Results posted to the registry on 7 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ECE Center Changes and Changes in Child Physical Activity	112	49

Primary outcome: Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.

Time frame: 1 year. Mean (Standard Error). Unit: minutes

Measure	ECE Center Changes and Changes in Child Physical Activity n = 112
Active Play (minutes)	-.12 (.05)
Television viewing (minutes)	.21 (.28)
Non-television screen-time (minutes)	.25 (.10)
Television screen-time (minutes)	.21 (.11)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECE Center Changes and Changes in Child Physical Activity	0 of 112 (0%)	0 of 112 (0%)	0 of 112

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32209069Kracht 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.
Results publication: PubMed 30199286Staiano 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.
Results publication: PubMed 29755053Staiano 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.
Results publication: PubMed 31384633Joseph 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.
Results publication: PubMed 30997257Webster 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.
Results publicationMartins, 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
Results publication: PubMed 32653249Kracht 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.
Results publication: PubMed 31491748Kracht 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.
Derived from this study: PubMed 42151099Webster EK, Spring KE, Moore JX, Brandon D, Staiano AE. Diverging Paths: Longitudinal and Reciprocal Associations Between Two Fundamental Motor Skill Assessments in Preschoolers. Child Care Health Dev. 2026 May;52(3):e70295. doi: 10.1111/cch.70295.
Individual participant dataSharing planned: No

Related trials for Childhood Obesity

Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda E Staiano, PhD principal investigator

PBRC Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02751788, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.