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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-11
SponsorAugusta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Voucher for Afterschool Care

    Behavioral

    Intervention includes a voucher for afterschool care and enrollment assistance

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: AB Group (Intervention in Fall)Other 1 intervention
Group B: BA Group (Intervention in Spring)Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
9 months (end of spring semester)
2

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.

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)
3

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.

Time frame
9 months (end of spring semester)
4

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.

Time frame
Baseline (beginning of fall semester) , 5 months (beginning of spring semester)

Secondary outcomes

1

Average proportion of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity during the intervention condition compared to comparison condition

An AX3 Axivity placed on children's non-dominate wrist will be used to collect minutes of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity (data processed using Hildebrand thresholds).

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)
2

Average proportion of afterschool time spent sedentary during the intervention condition compared to comparison condition

An AX3 Axivity placed on children's non-dominate wrist will be used to collect minutes of afterschool time (14:30-19:00) spent sedentary (data processed using Hildebrand thresholds).

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)
3

Average duration of daily screen use during the intervention condition compared to comparison condition

Parent-reported minutes spent using a screen (e.g., phone, computer, television) collected via electronic daily diaries will be used to calculate average duration of daily screen use.

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)
4

Average sleep midpoint during the intervention condition compared to comparison condition

Parent-reported sleep log and Ax3 Axivity on non-dominate wrist will be used to calculate the average time halfway between sleep onset and offset (hh:mm).

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)

Other outcomes

1

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

Age-and-sex standardized calculation of body mass index for children using height measuared in cm and weight measured in kg.

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)
2

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

Change in proportion of body fat (presented as a percent, initially measured in kg)

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)
3

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

Change in age-and-sex specific blood pressure percentile (presented as a percentile, initially measured in mmHg).

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)
4

Within-person change in total cholesterol during the intervention condition compared to comparison condition

Change in total cholesterol measured in mmol/L

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)

Locations

This trial has no locations.

Sponsors and contacts

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Augusta University

Lead sponsor

American Heart Association

Collaborator

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