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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Proportion of families who complete the study (RE-AIM: Individual Reach) [Срок оценки: 9 months (end of spring semester)]
• Proportion of children who attend afterschool care during intervention allocation (RE-AIM: Individual Implementation) [Срок оценки: 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) [Срок оценки: 9 months (end of spring semester)]
• Portion of clinics and clinicians that participate in prescribing afterschool care (REAIM: Setting-level Adoption) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗