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Идёт набор NCT06414668

The ENERGYCO Study

Без фазы С лечением Energy Expenditure Physical Activity Behavior Body Composition

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: Cycling Intervention Group.
Кому может быть актуально
Состояния в реестре: Energy Expenditure, Physical Activity, Behavior, Body Composition. Базовые параметры: 12 лет — 17 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

ENERGY Expenditure of COmmuting to School

Обзор

The aims of this school-based cycling intervention called "ENERGY Commuting to school" (ENERGYCO) will be divided into two phases: Phase I will aim: 1) to design, test, and validate predictive equations for the objective quantification of the energy expenditure related to different modes of commuting to school (i.e., walking, cycling, motorized-vehicle); and 2) to quantify the energy expenditure of each mode of commuting to school using indirect calorimetry in adolescents; and Phase II will aim to evaluate the effect of a school-based cycling intervention on different health-related outcomes, such as energy expenditure, resting metabolic rate, basal metabolism, physical activity levels, body composition, muscle strength, cardiorespiratory fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes on Spanish adolescents.

Подробное описание

The ENERGYCO study is a cluster-randomized controlled trial focused on the energy expenditure associated with commuting to school. Phase I will aim to develop predictive equations for quantifying energy expenditure during different modes of commuting (walking, cycling, motorized-vehicle) and to measure energy expenditure using indirect calorimetry in adolescents. Phase II will assess the impact of a school-based cycling intervention on various health outcomes in Spanish adolescents, including energy expenditure, metabolic rate, physical activity levels, body composition, muscle strength, fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes. Phase I will involve recruiting approximately 50 adolescents to quantify energy expenditure during walking, cycling, and motorized-vehicle. For Phase II, a random sample of around 300 schoolchildren aged 12-16 from three Spanish cities will undergo a eight-week cycling intervention involving Bikeability sessions and encouragement strategies. Therefore, the ENERGYCO study aims to develop predictive equations for measuring energy expenditure during active commuting to school and assess the impact of a cycling intervention on adolescent health. It is expected to contribute significantly to research and society by providing insights into the effects of active commuting and cycling interventions on adolescent energy expenditure, physical and mental health.

Вмешательства

  • Поведенческое Cycling Intervention Group
    A eight-weeks school-based cycling program. The school-based cycling intervention consists of 2 Bikeability sessions of 60 min at Physical Education lessons in school, and will focus on promote biking through theory and practice lessons about cycle training skills including on-road training. In addition, participants will receive encouragement strategies, one for each week of the intervention, for cycling to and from school during eight weeks.

Первичные конечные точки

  • Change of the resting metabolic rate [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of the daily energy expenditure [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
Вторичные конечные точки (12)
  • Change of Physical activity levels [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Heart rate monitoring [Срок оценки: During the 8 weeks when the participant will cycle to and from school]
  • Resting heart rate monitoring [Срок оценки: First weekend of the school-based cycling intervention]
  • Cycling skill assessment: Bikeability sessions [Срок оценки: First week of the school-based cycling intervention]
  • Change of physical fitness [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of physical literacy [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of anthropometric measures [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of anthropometric measures [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of body composition [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of cognitive determinants [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change of perceptions to active commuting to and from school [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]
  • Change in children's psychosocial variables [Срок оценки: 8 weeks during both measurement points (Baseline and post-intervention)]

Критерии участия

Критерии включения

  • the school has a specific space for parking bicycles and allows for their parking
  • the school does not have a specific school bus route
  • the school has at least two lines per class
  • at least eight students from the school will agree to participate in the study (i.e., presenting a signed parental consent).

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
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • University of Granada — Granada

Идентификаторы

NCT: NCT06414668 · ENERGYCO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗