Childhood ObesityPause and PlayNCT02751775
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 3
An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The objective is to establish community priorities for strategies to improve young children's health behaviors based on focus groups of stakeholders in the greater Baton Rouge area. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population will include parents and childcare directors.
Who may be able to join
- Either a director of a licensed childcare center in East Baton Rouge Parish OR a legal guardian and/or primary caretaker of a child aged 3 to 5 years who is enrolled in a licensed childcare center
- Able to understand and speak English
- Willing to be audio-taped during the focus group (for transcription purposes)
Who cannot join
- Being affiliated with 1 of the 10 childcare centers being assessed for Pause and Play Aims 1 or 2, either as a director/teacher or as a parent of a student
- Cognitive impairments that interfere with participation in a group discussion
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 3
The objective is to establish community priorities for strategies to improve young children's health behaviors based on focus groups of stakeholders in the greater Baton Rouge area.
Read the detailed description
Pause and Play (Aim 3) objective will be achieved through a series of taskforce and focus group meetings administered by the Mayor's Healthy City Initiative (MHCI). Meetings will include monthly meetings of the MHCI advisory boards composed of community stakeholders and focus groups of childcare center directors and parents. Stakeholders will create dissemination and implementation plans to leverage the findings of the project. We plan to conduct 2-3 focus groups of 8-10 parents and childcare directors, for a total of 16-30 participants. Participation in the focus group part of the study will last approximately 1 day.
- Conditions
- Childhood Obesity
- Keywords
- Childcare center regulations, Physical Activity, Sedentary Behavior, Screen-Time Behavior, Focus groups
- 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.
Qualitative Concepts, Themes and Quotes of focus group participants
Generation of key words, phrases, and quotes coded as variable themes agreed upon by at least one other participant in the group and repeated independently in other focus groups. Transcripts will be imported into NVivo software (Version 10, QSR, Victoria, Austrailia) to allow for thematic evaluation. The evaluation process will include the following: 1) generation of key words, phrases, and quotes coded as variable themes agreed upon by at least one other participant in the group and repeated independently in another focus group; 2) grouping of variables based on unifying concepts and themes; and 3) review of the variable groupings to ensure consistency and relevance of proposed unifying concepts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, Principal investigator, PBRC Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751775
- Sponsor's protocol ID
- PBRC 2015-045
- Other IDs
- U54MD008602-P02UAB, U54MD008602
- Acronym
- Pause and Play
- Status last verified
- Mar 2024
- First submitted
- 19 Apr 2016
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 31384633Staiano 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 29755053Kracht 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 32209069Webster 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 30997257Staiano 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 30199286Martins, 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 32653249Kracht 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
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 3
- ClinicalTrials.gov ID
- NCT02751775
- Acronym / sponsor ID
- Pause and Play / PBRC 2015-045
- Conditions
- Childhood Obesity
- Keywords
- Childcare center regulations, Physical Activity, Sedentary Behavior, Screen-Time Behavior, Focus groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to establish community priorities for strategies to improve young children's health behaviors based on focus groups of stakeholders in the greater Baton Rouge area.
Detailed description
Pause and Play (Aim 3) objective will be achieved through a series of taskforce and focus group meetings administered by the Mayor's Healthy City Initiative (MHCI). Meetings will include monthly meetings of the MHCI advisory boards composed of community stakeholders and focus groups of childcare center directors and parents. Stakeholders will create dissemination and implementation plans to leverage the findings of the project. We plan to conduct 2-3 focus groups of 8-10 parents and childcare directors, for a total of 16-30 participants. Participation in the focus group part of the study will last approximately 1 day.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will include parents and childcare directors.
Key inclusion criteria (3 listed)
- Either a director of a licensed childcare center in East Baton Rouge Parish OR a legal guardian and/or primary caretaker of a child aged 3 to 5 years who is enrolled in a licensed childcare center
- Able to understand and speak English
- Willing to be audio-taped during the focus group (for transcription purposes)
Key exclusion criteria (2 listed)
- Being affiliated with 1 of the 10 childcare centers being assessed for Pause and Play Aims 1 or 2, either as a director/teacher or as a parent of a student
- Cognitive impairments that interfere with participation in a group discussion
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
Qualitative Concepts, Themes and Quotes of focus group participants
Time frame: 6 months
Generation of key words, phrases, and quotes coded as variable themes agreed upon by at least one other participant in the group and repeated independently in other focus groups. Transcripts will be imported into NVivo software (Version 10, QSR, Victoria, Austrailia) to allow for thematic evaluation. The evaluation process will include the following: 1) generation of key words, phrases, and quotes coded as variable themes agreed upon by at least one other participant in the group and repeated independently in another focus group; 2) grouping of variables based on unifying concepts and themes; and 3) review of the variable groupings to ensure consistency and relevance of proposed unifying concepts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- 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 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 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 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 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 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.
- Individual participant dataSharing planned: No
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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 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualitative Concepts, Themes and Quotes of focus group participants (time frame: 6 months). 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 NCT02751775, which also lists 8 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.