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Идёт набор NCT05867433

Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

Без фазы С лечением Cardiovascular Diseases Nutrition Physical Activity

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: STHS Intervention, Usual Care.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Nutrition, Physical Activity. Базовые параметры: от 8 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 →

Обзор

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

Подробное описание

The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.

Title 1 middle schools in Texas (n=20) with \> 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).

The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.

Вмешательства

  • Поведенческое STHS Intervention
    STHS program The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmenta
  • Поведенческое Usual Care
    No STHS program The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.

Первичные конечные точки

  • Presence or absence of metabolic syndrome (MetS) [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Change in the number of MetS risk factors [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Positive Youth Development score [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
Вторичные конечные точки (12)
  • Blood pressure level [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Concentration of blood glucose [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Waist circumference [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Concentration of HDL cholesterol [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Concentration of serum triglycerides [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Height [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Weight [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Body mass index (BMI) [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Concentration of subdermal carotenoids [Срок оценки: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]
  • Accelerometer-derived physical activity estimation [Срок оценки: Baseline to 9 months]
  • Sedentary time [Срок оценки: Baseline to 9 months]
  • Time spent sleeping [Срок оценки: Baseline to 9 months]

Критерии участия

School Inclusion Criteria:

  • > 50 6th and 7th grade students
  • > 40% economically disadvantaged students
  • > 40% Black and Hispanic students

School Exclusion Criteria:

Student Inclusion Criteria:

  • 6th or 7th grade student
  • Attend a Title 1 middle school that is participating in the STHS intervention
  • Read and understand English

Student Exclusion Criteria:

  • Participation in a weight loss program in the past 3 months
  • Presence of a condition that prevents participation in physical activity

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

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

Публикации

  • MacMillan Uribe AL, George A, McNeely A, Xin L, Largacha Cevallos E, Rethorst C, Seguin Fowler RA, Szeszulski J. Strong Teens for Healthy Schools: Protocol for evaluating a youth nutrition, physical activity, and civic engagement protocol. Front Public Health. 2025 Sep 17;13:1654678. doi: 10.3389/fpubh.2025.1654678. eCollection 2025. PMID 41041380

Идентификаторы

NCT: NCT05867433 · IRB2022-1159D · R01MD018214

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗