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| ID | Type | Description | Link |
|---|---|---|---|
| 25CDA1451733 | Other Grant/Funding Number | American Heart Association | |
| Career Development Award | Other Grant/Funding Number | Augusta University |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| BA Group (Intervention in Spring) | Other | No afterschool voucher or enrollment assistance provided in the fall semester but is provided in the spring semester |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voucher for Afterschool Care | Behavioral | Intervention includes a voucher for afterschool care and enrollment assistance |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 803.602.4674 | lvonklinggraeff@augusta.edu |
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Study documents including study protocols, data management procedures, and deidentified individual participate data will be made available on Open Science Framework (DOI 10.17605/OSF.IO/H7VBT).
Upon publication of results with no end date
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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ORBIT Phase IIb preliminary, randomized crossover trial
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| 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) |
| 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). | 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 | 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. | 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 | 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). | 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 | Change in proportion of body fat (presented as a percent, initially measured in kg) | 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 | Change in age-and-sex specific blood pressure percentile (presented as a percentile, initially measured in mmHg). | 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 total cholesterol during the intervention condition compared to comparison condition | Change in total cholesterol measured in mmol/L | 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 HbA1c across the school year | Change in HbA1c measured in mmol/mol | Baseline (beginning of fall semester) to 9 months (end of spring semester) |