Afterschool Rx 2.0: Prescriptions to Afterschool Care for Pediatric Cardiovascular Risk Reduction

Official title

Advancing Pediatric Cardiovascular Health Through Afterschool Care: A Preliminary Randomized Controlled Trial

Overview

The goal of this clinical trial is to learn if "prescribing" afterschool care to children at risk for poor heart health later in life increases their physical activity and improves their heart health. 'Prescriptions' will be provided by pediatricians at participating Federally Qualified Health Centers and vouchers to existing afterschool programs (e.g., YMCA, Boys and Girls Clubs) will be provided by the research study. The main questions this study aims to answer are: Can afterschool care providers and health care providers easily offer and keep using the voucher program? Will families use the voucher? Do they go to afterschool care regularly, and do the families who use them represent a wide range or backgrounds? Does going to afterschool care help children be more physical activity? Does going to afterschool care improve heart health? Researchers will compare two randomly assigned time periods; one semester when families get the voucher and one semester where they do not. They will look at whether use of the afterschool care voucher leads to more physical activity and improved heart health.

Interventions

• Behavioral Voucher for Afterschool Care
  Intervention includes a voucher for afterschool care and enrollment assistance

Primary outcome measures

• Proportion of families who complete the study (RE-AIM: Individual Reach) [Time frame: 9 months (end of spring semester)]
• Proportion of children who attend afterschool care during intervention allocation (RE-AIM: Individual Implementation) [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) and 5 months (beginning of spring semester) to 9 months (end of spring semester)]
• Proportion of families that express a desire to continue attending afterschool care after the study ends (RE-AIM: Potential Maintenance) [Time frame: 9 months (end of spring semester)]
• Portion of clinics and clinicians that participate in prescribing afterschool care (REAIM: Setting-level Adoption) [Time frame: Baseline (beginning of fall semester) , 5 months (beginning of spring semester)]
• Proportion of afterschool programs providing afterschool care to study participants (REAIM: Setting-level adoption) [Time frame: Baseline (beginning of fall semester), 5 months (beginning of spring semester)]
• The number of days and daily hours participating afterschool programs opperate (REAIM: Setting-level Implementation) [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) , 5 months (beginning of spring semester) to 9 months (end of spring semester)]

Secondary outcome measures (4)

• Average proportion of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity during the intervention condition compared to comparison condition [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)]
• Average proportion of afterschool time spent sedentary during the intervention condition compared to comparison condition [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)]
• Average duration of daily screen use during the intervention condition compared to comparison condition [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)]
• Average sleep midpoint during the intervention condition compared to comparison condition [Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)]

Eligibility criteria

Inclusion criteria

• A child must be entering 1st-4th grade when recruited (i.e., 5-11 years old)
• A child must have one or more cardiovascular risk factors as identified by a clinical care provider (i.e., obesity, hypertension, hyperglycemia, hyperlipidemia)
• Attend an elementary school patterned with a participating afterschool program
• Belong to a family at or below 250% of the federal poverty level
• The participating parent/guardian must have a phone that accepts text messages

Exclusion criteria

• If the child does not meet the inclusion criteria for attending the participating afterschool programs (e.g., children that require specially trained staff to safely provide care),
• If the child is pregnant
• If it is unsafe for the child to participate in any of the study measures as determined by their clinical care provider (i.e., can not safely complete a 6-min walk test or finger stick)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07096167 · IRBNet ID 2316862 · 25CDA1451733 · Career Development Award

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗