The ENERGYCO Study

Not Applicable

Recruiting

• Conditions: Behavior; Physical Activity; Energy Expenditure; Body Composition
• Interventions: Behavioral: Cycling Intervention Group

• Registration Number: NCT06414668
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycling group	Cycling Intervention Group	The intervention will include two Bikeability sessions and encouragements strategies will be carried out to complete the eight-weeks intervention based on cycling to and from school

Primary Outcome Measures

Name	Time	Method
Change of the resting metabolic rate	8 weeks during both measurement points (Baseline and post-intervention)	Assessment of the resting metabolic rate using indirect calorimetry (Ominical)
Change of the daily energy expenditure	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 Outcome Measures

Name	Time	Method
Change of Physical activity levels	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
Heart rate monitoring	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
Resting heart rate monitoring	First weekend of the school-based cycling intervention	Assessment of the resting heart rate using a pulsometer
Cycling skill assessment: Bikeability sessions	First week of the school-based cycling intervention	Assessment of the cycling skills in a closed circuit
Change of physical literacy	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)
Change of physical fitness	8 weeks during both measurement points (Baseline and post-intervention)	Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope )
Change of anthropometric measures	8 weeks during both measurement points (Baseline and post-intervention)	Assessment of waist and neck circumference in centimeters
Change of body composition	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)
Change of cognitive determinants	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
Change of perceptions to active commuting to and from school	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)
Change in children's psychosocial variables	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)
Family socioeconomic status	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)
Change of parental perceptions	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)
Children sociodemographic characteristics	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
Parents sociodemographic characteristics	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
Distance home-school-home	8 weeks during both measurement points (Baseline and post-intervention)	Assessment of the route characteristics using Google Maps and GPS
Weather	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
School characteristics	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
City characteristics	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

Trial Locations

Locations (1)

University of Granada; 🇪🇸 Granada, Spain