跳至主要内容
临床试验/NCT06414668
NCT06414668招募中不适用

ENERGY Expenditure of COmmuting to School

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Change of the daily energy expenditure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 未提供

结局指标

主要结局

Change of the daily energy expenditure

时间窗: 8 weeks during both measurement points (Baseline and post-intervention)

Assessment of the energy expenditure using predictive equations developed during the Phase I of the stuy and validated against indirect calorimetry (Cosmed K5)

Change of the resting metabolic rate

时间窗: 8 weeks during both measurement points (Baseline and post-intervention)

Assessment of the resting metabolic rate using indirect calorimetry (Ominical)

次要结局

  • Change of Physical activity levels(8 weeks during both measurement points (Baseline and post-intervention))
  • Heart rate monitoring(During the 8 weeks when the participant will cycle to and from school)
  • Resting heart rate monitoring(First weekend of the school-based cycling intervention)
  • Cycling skill assessment: Bikeability sessions(First week of the school-based cycling intervention)
  • Change of physical literacy(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of physical fitness(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of body composition(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of cognitive determinants(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of perceptions to active commuting to and from school(8 weeks during both measurement points (Baseline and post-intervention))
  • Family socioeconomic status(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of parental perceptions(8 weeks during both measurement points (Baseline and post-intervention))
  • Children sociodemographic characteristics(8 weeks during both measurement points (Baseline and post-intervention))
  • Parents sociodemographic characteristics(8 weeks during both measurement points (Baseline and post-intervention))
  • Distance home-school-home(8 weeks during both measurement points (Baseline and post-intervention))
  • Weather(8 weeks during both measurement points (Baseline and post-intervention))
  • City characteristics(8 weeks during both measurement points (Baseline and post-intervention))
  • Change of anthropometric measures(8 weeks during both measurement points (Baseline and post-intervention))
  • Change in children's psychosocial variables(8 weeks during both measurement points (Baseline and post-intervention))
  • School characteristics(8 weeks during both measurement points (Baseline and post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emilio Villa González

Professor

Universidad de Granada

研究点 (2)

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