- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06414668
The ENERGYCO Study (ENERGYCO)
May 9, 2024 updated by: Emilio Villa González, Universidad de Granada
ENERGY Expenditure of COmmuting to School
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain, 18071
- Recruiting
- University of Granada
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Contact:
- Emilio Villa-González, PhD
- Phone Number: 637942790
- Email: evilla@ugr.es
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cycling 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
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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.
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No Intervention: Control group
The control group will keep their usual mode of commuting to and from school.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the resting metabolic rate
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the resting metabolic rate using indirect calorimetry (Ominical)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of the daily energy expenditure
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the energy expenditure using predictive equations developed during the Phase I of the stuy and validated against indirect calorimetry (Cosmed K5)
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8 weeks during both measurement points (Baseline and post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Physical activity levels
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the physical activity levels using accelerometry and the "Youth Physical Activity Profile" questionnaire
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8 weeks during both measurement points (Baseline and post-intervention)
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Heart rate monitoring
Time Frame: During the 8 weeks when the participant will cycle to and from school
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Assessment of the intensity of the commuting by bike to and from school using a pulsometer
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During the 8 weeks when the participant will cycle to and from school
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Resting heart rate monitoring
Time Frame: First weekend of the school-based cycling intervention
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Assessment of the resting heart rate using a pulsometer
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First weekend of the school-based cycling intervention
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Cycling skill assessment: Bikeability sessions
Time Frame: First week of the school-based cycling intervention
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Assessment of the cycling skills in a closed circuit
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First week of the school-based cycling intervention
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Change of physical fitness
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope )
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of physical literacy
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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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)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of anthropometric measures
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of anthropometric measures
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of waist and neck circumference in centimeters
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of body composition
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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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)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of cognitive determinants
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of subjective norm, intention, perceived behavioral control and attitude using Questionnaire stages of change
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of perceptions to active commuting to and from school
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of perceived barriers to active commute to school using the Barriers for active commuting to school questionnaire (BATACE)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change in children's psychosocial variables
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of autonomy, competence, and relatedness using the Basic Pshychological Need Satisfaction Need in Active Commuting to and from School questionnaire (BPNS ACS)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change in children's psychosocial variables
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of satisfaction and motivation to active commuting to and from school using the Behavioural Regulation in Active Commuting to and from School questionnaire
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8 weeks during both measurement points (Baseline and post-intervention)
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Change in children's psychosocial variables
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of self-Esteem and mental health using the Positive and Negative Affect Schedule and the Rosenberg Self-Esteem Scale (RSES)
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8 weeks during both measurement points (Baseline and post-intervention)
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Children sociodemographic characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Participants self-report their age, school grade and class, gender, full postal address, bicycle owners through a student questionnaire
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8 weeks during both measurement points (Baseline and post-intervention)
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Parents sociodemographic characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Parents self-report the school name, child name, age, gender, children´s gender, and full postal address, parental education level through a parents questionnaire
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8 weeks during both measurement points (Baseline and post-intervention)
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Family socioeconomic status
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Children and parents self-report their family income using the Family Affluence Scale questionnaire (FAS III)
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8 weeks during both measurement points (Baseline and post-intervention)
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Change of parental perceptions
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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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)
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8 weeks during both measurement points (Baseline and post-intervention)
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Distance home-school-home
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the route characteristics using Google Maps and GPS
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8 weeks during both measurement points (Baseline and post-intervention)
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Weather
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the Temperature (maximum, minimum, mean), total rainfall, and mean wind speed using data from the National Weather Data Bank
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8 weeks during both measurement points (Baseline and post-intervention)
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School characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the school enrolment by electronic and manual search
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8 weeks during both measurement points (Baseline and post-intervention)
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School characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the school socioeconomic status using Geographical Information System
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8 weeks during both measurement points (Baseline and post-intervention)
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School characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the school engagement using data from the Ministry of Education and Vocational Training
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8 weeks during both measurement points (Baseline and post-intervention)
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City characteristics
Time Frame: 8 weeks during both measurement points (Baseline and post-intervention)
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Assessment of the population density and city income using data from the Tax Agency, Spanish Public Ministry of Finance and Public Administration of Spain
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8 weeks during both measurement points (Baseline and post-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ENERGYCO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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