Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers

Exercise Clinical Trial

— BESAGE  

Official title:

Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05178290
• Other study ID #: STUDY00014151
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to get children safely back to school by (1) Child and Family Testing, (2) ECE Personnel Testing, and (3) Outdoor Learning via Garden Education.

Description:

This study aims to get children safely back to school with a three strategy approach. 1. Child and Family Testing. Investigators will determine acceptability, feasibility, efficacy and scalability of testing children and families as a pre-screening strategy for re-entry to 40 CACFP-eligible ECE sites for fall 2021. Our trained bilingual ASU team (vaccinated staff and nursing students) will provide onsite testing ECE sites. Investigators will assess acceptability and feasibility via brief parent surveys and developmentally appropriate icon ratings for children, and assess efficacy as the proportion of viable samples obtained, coaching time needed to obtain one sample, and proportion of successfully obtained samples. Investigators will document costs of delivering the screening strategy (e.g., personnel, time, materials) to determine scalability. For participants testing positive for COVID-19, community health workers from Equality Health Services will provide follow-up care. 2. ECE Personnel Testing. Investigators will determine the acceptability, feasibility, efficacy and scalability of routine ECE screening of ECE personnel (teachers and aides) who have direct contact with children. Investigators will determine the acceptability of screening by 6-8 focus groups with teachers (N=80) from the 40 ECE sites above in July. Investigators will measure feasibility and efficacy (agree to test, proportion of viable samples obtained) of bi-weekly ECE site-based testing with school personnel from half (20) of the sites for fall 2021. Investigators will survey teachers to determine how acceptability toward testing relates to importance for back to ECE safety changes as vaccine uptake increases and vaccine hesitancy decreases over time. Investigators will record costs (e.g., personnel, time, materials) to determine scalability. Investigators will determine the additive efficacy of both child testing (see #1) and ECE personnel testing on attendance and enrollment. For participants testing positive for COVID-19, community health workers from Equality Health Services will provide follow-up care. 3. Outdoor Learning via Garden Education. Investigators will determine the efficacy of enhanced outdoor learning opportunities for closing the gap from the lack of in person based ECE on motor development and eating in the absence of hunger in 4 and 5 year olds. Investigators will randomize participating sites to engage in an adapted Sustainability via Active Garden Education (SAGE) garden curriculum in Spring of 2022 or wait list. Wait list sites will receive the garden and curriculum in Fall 2022. Investigators will install or enhance existing gardens in ECE sites to promote outdoor learning opportunities linked to NAEYC guidelines, and expect children in those sites to gain more rapid improvements following the learning gap. Using established protocols Investigators will test children on motor behavior and eating in the absence of hunger in Fall of 2021 (T1, baseline), prior to implementing SAGE, in Spring 2022, following SAGE implementation, and then a follow up in Fall of 2022 to determine ongoing effects.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3280
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion

• Adult parents and their minor children (age 3-5)
• Children and their parents who are attending eligible early care and education (ECE) sites
• ECE site personnel (adults 18 and older) with direct contact of children attending ECE sites. Exclusion -Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.

Related Conditions & MeSH terms

• Child Development
• Children, Preschool
• COVID-19
• COVID-19 Testing
• Diet, Healthy
• Exercise
• Parents
• Self-Control

Intervention

Behavioral:
• CHILD back-to-ECE COVID-19 saliva testing
Preschool children and their parent will complete saliva COVID-19 tests at the start of the school year and after winter break as part of a back-to-ECE safely intervention. Tests may be completed during pick up, at drop off, or during school, depending on local on-campus regulations.
• ECE personnel back-to-ECE COVID-19 saliva screening
ECE personnel will complete saliva COVID-19 tests biweekly through the school year as part of a back-to-ECE safely intervention. Tests may be completed on the ECE campus or in the parking lot, depending on local on-campus regulations
• SAGE garden programming
The SAGE garden programming includes installation of a garden; teacher training via Zoom and/or short videos, a binder and website support along with other accompanying materials and teacher technical support (email, text, phone); gardening supplies and gear (e.g., hats, watering cans, gloves); and delivers active songs, games, science experiments and other outdoor learning opportunities.

Locations

Country	Name	City	State
United States	Arizona State University-Downtown Campus	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Tier 1 Common Data Element (PhenX Toolkit): Age (Demo), Annual Family Income (Demo), Employment Status (Demo), Educational Attainment (Demo), Gender (Demo), Ethnicity/Race (Demo), Health Insurance Coverage (Demo)	Time 1 Baseline start of the semester
Other	Vulnerability and Exposure to COVID-19 and Vaccine Acceptance	RADx-UP measure from the PhenX Toolkit of Vulnerability and Exposure to COVID-19 and Vaccine Acceptance	Time 1 Baseline start of the semester
Primary	Viable sample	Proportion of viable saliva samples obtained from children	Within six weeks from the start of school (varies by site and semester)
Primary	Proportion of Children Attending ECE	Aggregated weekly attendance of children in ECE sites and comparison (non-participating) sites.	within four weeks of the end of school (varies by site and semester)
Primary	Progressive Aerobic Cardiovascular Endurance Run (PACER)	Product-based quantitative, locomotor skills test	Baseline pre-intervention
Primary	Progressive Aerobic Cardiovascular Endurance Run (PACER)	Product-based quantitative, locomotor skills test	Post-test up to four weeks after intervention
Primary	Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol	Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping	Baseline pre-intervention
Primary	Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol	Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping	Posttest up to four week post-intervention
Primary	Eating in the absence of hunger	Behavioral, quantitative test of eating when one is not hungry	Baseline pre-intervention
Primary	Eating in the absence of hunger	Behavioral, quantitative test of eating when one is not hungry	Posttest up to four weeks post-intervention
Secondary	Acceptability and feasibility of saliva COVID-19 test	Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test.	At time of COVID-19 test within six weeks from the start of school (varies by site and semester)
Secondary	Cost to obtain a sample	Cost including personnel, time, materials, space to obtain a sample	Time 1 at the time of COVID-19 test, Within six weeks from the start of school (varies by site and semester)
Secondary	Parent reports of COVID-19 household incidence	Brief questionnaire that measures self-report of COVID-19 cases in households enrolled in the project completed by parents approximately once per month	Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)