Clinical trial NCT06414668: The ENERGYCO Study
Official title: ENERGY Expenditure of COmmuting to School
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Energy Expenditure
Physical Activity
Behavior
Body Composition
Keywords: Resting metabolic rate
Energy expenditure
Physical activity
Body composition
Cycling
School
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: University of Jaén
name: Navarra Institute for Health Research
name: Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición
name: University of Otago
First posted: 2024-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change of the resting metabolic rate
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of the daily energy expenditure
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
Secondary outcomes:
measure: Change of Physical activity levels
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Heart rate monitoring
timeFrame: During the 8 weeks when the participant will cycle to and from school
measure: Resting heart rate monitoring
timeFrame: First weekend of the school-based cycling intervention
measure: Cycling skill assessment: Bikeability sessions
timeFrame: First week of the school-based cycling intervention
measure: Change of physical fitness
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of physical literacy
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of anthropometric measures
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of anthropometric measures
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of body composition
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of cognitive determinants
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of perceptions to active commuting to and from school
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change in children's psychosocial variables
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change in children's psychosocial variables
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change in children's psychosocial variables
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Children sociodemographic characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Parents sociodemographic characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Family socioeconomic status
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Change of parental perceptions
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Distance home-school-home
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: Weather
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: School characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: School characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: School characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
measure: City characteristics
timeFrame: 8 weeks during both measurement points (Baseline and post-intervention)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References: