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

NCT ID: NCT07096167

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AB Group (Intervention in Fall)

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

Group Type: OTHER

Voucher for Afterschool Care

Intervention Type: BEHAVIORAL

Intervention includes a voucher for afterschool care and enrollment assistance

BA Group (Intervention in Spring)

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

Group Type: OTHER

Voucher for Afterschool Care

Intervention Type: BEHAVIORAL

Intervention includes a voucher for afterschool care and enrollment assistance

Interventions

Voucher for Afterschool Care

Intervention includes a voucher for afterschool care and enrollment assistance

Intervention Type: BEHAVIORAL

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

• 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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Lauren von Klinggraeff

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Principal Investigator

Role: CONTACT

lvonklinggraeff@augusta.edu

803.602.4674

Other Identifiers

25CDA1451733

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Career Development Award

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRBNet ID 2316862

Identifier Type: -

Identifier Source: org_study_id