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NCT Number: NCT06414668

The ENERGYCO Study

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.

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Key information

Conditions

Energy Expenditure Behavior Body Composition Motor Activity Physical Activity

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18071, Spain

Location status: Recruiting

Location contact

Emilio Villa-González, PhD

CONTACT

[email protected]

637942790

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Treatment and study plan

Cycling Intervention Group

Behavioral

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.

Primary outcomes

  1. Change of the resting metabolic rate

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

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

  2. Change of the daily energy expenditure

    Time frame: 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)

Secondary outcomes

  1. Change of Physical activity levels

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the physical activity levels using accelerometry and the "Youth Physical Activity Profile" questionnaire

  2. Heart rate monitoring

    Time frame: During the 8 weeks when the participant will cycle to and from school

    Assessment of the intensity of the commuting by bike to and from school using a pulsometer

  3. Resting heart rate monitoring

    Time frame: First weekend of the school-based cycling intervention

    Assessment of the resting heart rate using a pulsometer

  4. Cycling skill assessment: Bikeability sessions

    Time frame: First week of the school-based cycling intervention

    Assessment of the cycling skills in a closed circuit

  5. Change of physical fitness

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope )

  6. Change of physical literacy

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assesment of phsychological, social, cognitive, and motor competence using the Spanish perceived physical literacy instrument for adolescents (PPLI-Q) and the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)

  7. Change of anthropometric measures

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2)

  8. Change of anthropometric measures

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of waist and neck circumference in centimeters

  9. Change of body composition

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of fat free mass, fat mass, lean mass index, fat mass index, body fat percentage, visceral adipose tissue, and bone mineral content using Dual energy X-ray absorptimetry (DEXA)

  10. Change of cognitive determinants

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of subjective norm, intention, perceived behavioral control and attitude using Questionnaire stages of change

  11. Change of perceptions to active commuting to and from school

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of perceived barriers to active commute to school using the Barriers for active commuting to school questionnaire (BATACE)

  12. Change in children's psychosocial variables

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of autonomy, competence, and relatedness using the Basic Pshychological Need Satisfaction Need in Active Commuting to and from School questionnaire (BPNS ACS)

  13. Change in children's psychosocial variables

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of satisfaction and motivation to active commuting to and from school using the Behavioural Regulation in Active Commuting to and from School questionnaire

  14. Change in children's psychosocial variables

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of self-Esteem and mental health using the Positive and Negative Affect Schedule and the Rosenberg Self-Esteem Scale (RSES)

  15. Children sociodemographic characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Participants self-report their age, school grade and class, gender, full postal address, bicycle owners through a student questionnaire

  16. Parents sociodemographic characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Parents self-report the school name, child name, age, gender, children´s gender, and full postal address, parental education level through a parents questionnaire

  17. Family socioeconomic status

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Children and parents self-report their family income using the Family Affluence Scale questionnaire (FAS III)

  18. Change of parental perceptions

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the parents´ barriers to allow their adolescent to active commuting to and from school using the Parental Perception of Barriers towards active commuting to school questionnaire (PABACS)

  19. Distance home-school-home

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the route characteristics using Google Maps and GPS

  20. Weather

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the Temperature (maximum, minimum, mean), total rainfall, and mean wind speed using data from the National Weather Data Bank

  21. School characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the school enrolment by electronic and manual search

  22. School characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the school socioeconomic status using Geographical Information System

  23. School characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the school engagement using data from the Ministry of Education and Vocational Training

  24. City characteristics

    Time frame: 8 weeks during both measurement points (Baseline and post-intervention)

    Assessment of the population density and city income using data from the Tax Agency, Spanish Public Ministry of Finance and Public Administration of Spain

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición
  • Ministerio de Economía y Competitividad, Spain
  • Navarra Institute for Health Research
  • University of Jaén
  • University of Otago

Registry information

Official study title

ENERGY Expenditure of COmmuting to School

Acronym: ENERGYCO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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