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Идёт набор NCT07079995

Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial

Без фазы С лечением Cardiovascular Diseases Physical Activity Nutrition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mentoring program, Waitlist.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Physical Activity, Nutrition. Базовые параметры: 8 лет — 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to conduct a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT) to assess both Healthy School Recognized Campus (HSRC) and the mentoring program.

Подробное описание

This study uses a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT). DRCTs include two randomized controlled trials within the same study: one testing an intervention (i.e., HSRC) and one testing an implementation strategy (i.e., the mentoring program).

Schools in Central and East Texas (n=20) of similar socio-economic status will be randomized at baseline to either the HSRC condition or the Waitlist Control condition. In the HSRC condition, schools will attempt to deliver youth and adult physical activity or nutrition programs. In the Waitlist Control condition, schools will not add or remove any current physical activity and/or healthy eating programs, and will receive HSRC the next school year. Schools will also be randomized to receive the mentoring program or standard implementation immediately or after being a waitlist control.

Aim 1: Determine the effectiveness of the HSRC initiative compared to a control group on BMI-Z score, physical activity, and skin carotenoids (i.e., fruit and vegetable intake).

For Aim 1, the investigators will compare outcomes in 10 Texas schools that receive HSRC with 10 Waitlist Control communities.

Aim 2: Determine the impact of the mentoring program compared to standard implementation on short-term (acceptability, appropriateness, feasibility) and long-term (number of students reached, total dosage delivered) implementation outcomes.

For Aim 2, the investigators will compare outcomes in 10 Texas schools that receive the mentoring program with 10 that receive standard implementation.

Вмешательства

  • Поведенческое Mentoring program
    Schools in this group will participate in meetings and receive newsletters to help with program implementation.
  • Поведенческое Waitlist
    Schools in this group will wait 1 year to receive HSRC. Schools will not add or remove any current physical activity and/or healthy eating programs.

Первичные конечные точки

  • Body mass index (BMI) [Срок оценки: Baseline, 9 months]
  • Acceptability of the HSRC program [Срок оценки: Baseline, 9 months]
  • Appropriateness of the HSRC program [Срок оценки: Baseline, 9 months]
  • Feasibility of the HSRC program [Срок оценки: Baseline, 9 months]
Вторичные конечные точки (4)
  • Concentration of subdermal carotenoids [Срок оценки: Baseline, 9 months]
  • Accelerometer-derived physical activity estimation [Срок оценки: Baseline, 9 months]
  • Number of students reached [Срок оценки: Baseline, 9 months]
  • Total program dosage delivered [Срок оценки: Baseline, 9 months]

Критерии участия

School Inclusion Criteria:

  • located in Central and East Texas
  • Public school

Student Inclusion Criteria

  • enrolled in the 4th, 5th, 6th, 7th, 8th, or 9th grade
  • able to read, speak, and write in English

Student Exclusion Criteria:

  • any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Texas A&M AgriLife Dallas Center — Dallas

Публикации

  • Schaefers A, Beattie CM, de Mello GT, George A, Marstall K, Gardner J, Szeszulski J. Healthy school recognized campus: design and methodology of a hybrid type 2 implementation-effectiveness cluster randomized trial. Implement Sci. 2026 Feb 5;21(1):19. doi: 10.1186/s13012-026-01487-2. PMID 41645239

Идентификаторы

NCT: NCT07079995 · HSRC DRCT STUDY2025-0650

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗