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

NCT07096167 | Not Yet Recruiting

• 3 other identifiers: IRBNet ID 231686225CDA1451733Career Development Award
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular Risk Factor

Keywords

cardiovascular; out-of-school time; afterschool care; pediatric; physical activity

Outcome Measures

Primary Outcomes (6)

• Proportion of families who complete the study (RE-AIM: Individual Reach)

  Study logs will be used to determine the proportion of families who complete the study. Participants are considered to have completed the study if they do not withdraw or drop out. A successful outcome will be considered if ≥80% of families in both groups are retained in the study and families in both sequences (AB/BA) are retained in the study at equivalent rates.

  9 months (end of spring semester)

• Proportion of children who attend afterschool care during intervention allocation (RE-AIM: Individual Implementation)

  Attendance records provided by afterschool care programs will be used to determine the proportion of children who attend afterschool care during intervention allocation. Success will be defined as ≥80% of children attend afterschool care during intervention assignment.

  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)

  Qualitative interviews with families at the school year will be used to determine families' interest in continuing to utilize afterschool care. A successful outcome will be defined as ≥80% of families in both groups express a desire to continue attending afterschool care after study ends.

  9 months (end of spring semester)

• Portion of clinics and clinicians that participate in prescribing afterschool care (REAIM: Setting-level Adoption)

  Study records will be used to measure the proportion of clinics and clinicians that prescribe afterschool care to eligible children. A successful outcome will be defined as a referral rate of ≥60% eligible children.

  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)

  Study records will be used to measure the proportion of afterschool programs that are able and willing to provide afterschool care to children participating in the study. A successful outcome will be defined as having at least 8 available spots across participating programs each year (i.e., able to meet recruitment goals).

  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)

  Study records and random unannounced direct observation will be used to measure the number of days and daily hours the afterschool programs operate. A successful outcome will be defined as the afterschool programs being open and operational on days local elementary schools are open and operational and that the participating afterschool program follows preplanned schedule on ≥80% of observation days.

  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 Outcomes (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

  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

  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

  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

  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)

Other Outcomes (5)

• Within-person change in BMI z-score during the intervention condition compared to comparison condition

  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)

• Within-person change in percent fat mass during the intervention condition compared to comparison condition

  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)

• Within-person change in blood pressure percentile during the intervention condition compared to comparison condition

  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)

Study Arms (2)

AB Group (Intervention in Fall)

OTHER

Voucher for afterschool care and enrollment assistance provided in the fall semester, no intervention is provided in the spring semester

Behavioral: Voucher for Afterschool Care

BA Group (Intervention in Spring)

OTHER

No afterschool voucher or enrollment assistance provided in the fall semester but is provided in the spring semester

Behavioral: Voucher for Afterschool Care

Interventions

Voucher for Afterschool Care BEHAVIORAL

Intervention includes a voucher for afterschool care and enrollment assistance

AB Group (Intervention in Fall); BA Group (Intervention in Spring)

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Augusta University: lead
• American Heart Association: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Principal Investigator

CONTACT

803.602.4674; lvonklinggraeff@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: ORBIT Phase IIb preliminary, randomized crossover trial

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon publication of results with no end date