Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02751814
Other study ID # PBRC 2015-038
Secondary ID U54MD008602-P02U
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date June 2018

Study information

Verified date March 2024
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Pause and Play aims to enroll 266 children. Each child will participate in the study for approximately 1 year. Surveys, anthropometric measures, and screen-time observations will take approximately 1 day each to complete, and the child will be given an accelerometer to wear at home for 7 days at both baseline and 1 year follow-up. Fundamental motor skill assessments will take place at baseline and 1 year follow-up after the 7 days of accelerometer wear. Staff members will spend approximately 2 weeks at each childcare center at baseline and 1 year follow-up to complete study procedures with each child.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 4 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Parent/legal guardian is unwilling to provide written informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

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), 9

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in Classroom Observation of Child Screen-time Classroom observation of child screen-time will be measured with the Environment and Policy Assessment and Observation (EPAO) method to quantify average minutes/day screen-time in childcare center. Screen time will be assessed using classroom observation at the childcare center (from the EPAO observation in Aim 1). Results are reflecting changes in screen-time. 1 year
Secondary Parent Reports of Child Screen Time Parent reports of child screen time to quantify minutes/day screen-time total. Parents will complete a survey adapted to provide information about the child's screen-time (separately for TV, computer, games console and smartphone) on weekdays and weekend days. For each item the parent will be asked to report the time the child spent using it for (a) a normal weekday and (b) a normal weekend day, with response options: none; 1 to 30 minutes; 31 minutes to 1 hour; 1 to 2 hours; 2 to 3 hours; 3 to 4 hours; 4 hours or more. The assessment of TV viewing using parental report has been shown to correlate moderately (r=0.60) with 10 days of TV diaries among young children. 1 Year
Secondary Sedentary Behavior and Physical Activity Cross-sectional and longitudinal associations among sedentary behavior (by screen-time observation/self-report and accelerometry) and physical activity (by accelerometry). The mean and standard deviation for time sedentary behavior and physical activity are presented in the table below. 1 year
Secondary Fundamental Motor Skills Cross-sectional and longitudinal associations among Test of Gross Motor Development, 3rd edition (TGMD-3), and subscales (Ball Skills and Locomotor Skills). The TGMD-3 is a process-oriented assessment designed to assess gross motor performance of young children age 3-10 years. The total score for each item is established by the summation of all performance criteria scores for both trials, which are accumulated to determine the total locomotor and ball skills subtest scores and the overall TGMD-3 raw score for gross motor performance The maximum score a participant can obtain on locomotor is 46, for ball skills its 54, and overall gross motor performance is 100. The minimum score a child can receive is 0. Higher scores indicate better performance. Lower scores help identify delays and deficits in gross motor development in early childhood. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT01977105 - Healthy Growth Abbreviated Pilot Study N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT01290848 - A Health Promotion Campaign Targeting Caregivers of Young Children Phase 2