Trial Outcomes & Findings for Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1 (NCT NCT02751788)

NCT ID: NCT02751788

Last Updated: 2024-03-29

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

112 participants

Primary outcome timeframe

1 year

Results posted on

2024-03-29

Participant Flow

Participant milestones

Participant milestones
Measure
ECE Center Changes and Changes in Child Physical Activity
Aim 1 of this study was to evaluate the association among ECE center changes in practices, environment, staff behaviors, and policies, and changes in child physical activity and sedentary behavior while attending the ECE centers.
Overall Study
STARTED
112
Overall Study
COMPLETED
49
Overall Study
NOT COMPLETED
63

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ECE Center Changes and Changes in Child Physical Activity
n=49 Participants
Aim 1 of this study was to evaluate the association among ECE center changes in practices, environment, staff behaviors, and policies, and changes in child physical activity and sedentary behavior while attending the ECE centers.
Age, Categorical
<=18 years
49 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · White
37 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · African American
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Other
5 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
ECE Center Changes and Changes in Child Physical Activity
n=112 Participants
Aim 1 of this study was to evaluate the association among ECE center changes in practices, environment, staff behaviors, and policies, and changes in child physical activity and sedentary behavior while attending the ECE centers.
Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
Active Play (minutes)
-.12 minutes
Standard Error .05
Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
Television viewing (minutes)
.21 minutes
Standard Error .28
Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
Non-television screen-time (minutes)
.25 minutes
Standard Error .10
Change in Environment and Policy Assessment and Observation (EPAO) Score and EPAO Subscales.
Television screen-time (minutes)
.21 minutes
Standard Error .11

SECONDARY outcome

Timeframe: 1 Year

Population: Ten centers were enrolled in this Study. One site dropped out. The analysis provided is only year two.

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.

Outcome measures

Outcome measures
Measure
ECE Center Changes and Changes in Child Physical Activity
n=10 Participants
Aim 1 of this study was to evaluate the association among ECE center changes in practices, environment, staff behaviors, and policies, and changes in child physical activity and sedentary behavior while attending the ECE centers.
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Awareness of new policy (Year 2) · Yes
7 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Awareness of new policy (Year 2) · No
2 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Field Trips (Year 2) · Yes
5 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Field Trips (Year 2) · No
4 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Community organizations - provide physical activity programs (Year 2) · Yes
3 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Community organizations - provide physical activity programs (Year 2) · No
6 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are not allowed any screen time at the center (Year 2) · Yes
4 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are not allowed any screen time at the center (Year 2) · No
5 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are allowed at least 60 minutes of free play (Year 2) · Yes
9 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are allowed at least 60 minutes of free play (Year 2) · No
0 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are allowed at least 90 minutes of outdoor time (Year 2) · Yes
5 Participants
Changes in Practice-based Survey Items Based on Childcare Director Responses.
Children are allowed at least 90 minutes of outdoor time (Year 2) · No
4 Participants

Adverse Events

ECE Center Changes and Changes in Child Physical Activity

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amanda Staiano

LSU's Pennington Biomedical Research Center

Phone: 225.763.2500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place