Energy ExpenditureENERGYCONCT06414668
The ENERGYCO Study
A study testing Cycling Intervention Group in people with Energy Expenditure and Physical Activity, run by Universidad de Granada at 1 site in Spain.
Trial 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.… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Physical Activity, Behavior
- What is being tested?
- Cycling Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, 18071
Emilio Villa-González, PhD, 637942790, evilla@ugr.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Energy Expenditure, Physical Activity, Behavior, Body Composition
- Being tested
- Cycling Intervention Group
- Keywords
- Resting metabolic rate, Energy expenditure, Physical activity, Body composition, Cycling, School
- Medical subject headings
- Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling Intervention GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cycling group | Experimental | 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 Receives: Behavioral: Cycling Intervention Group |
| Control group | No intervention | The control group will keep their usual mode of commuting to and from school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the resting metabolic rate
Assessment of the resting metabolic rate using indirect calorimetry (Ominical)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of the daily energy expenditure
Assessment of the energy expenditure using predictive equations developed during the Phase I of the stuy and validated against indirect calorimetry (Cosmed K5)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Secondary outcomes (24)
Change of Physical activity levels
Assessment of the physical activity levels using accelerometry and the "Youth Physical Activity Profile" questionnaire
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Heart rate monitoring
Assessment of the intensity of the commuting by bike to and from school using a pulsometer
Measured: During the 8 weeks when the participant will cycle to and from school
Resting heart rate monitoring
Assessment of the resting heart rate using a pulsometer
Measured: First weekend of the school-based cycling intervention
Cycling skill assessment: Bikeability sessions
Assessment of the cycling skills in a closed circuit
Measured: First week of the school-based cycling intervention
Change of physical fitness
Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope )
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of physical literacy
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)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of anthropometric measures
Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of anthropometric measures
Assessment of waist and neck circumference in centimeters
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of body composition
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)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of cognitive determinants
Assessment of subjective norm, intention, perceived behavioral control and attitude using Questionnaire stages of change
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of perceptions to active commuting to and from school
Assessment of perceived barriers to active commute to school using the Barriers for active commuting to school questionnaire (BATACE)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Assessment of autonomy, competence, and relatedness using the Basic Pshychological Need Satisfaction Need in Active Commuting to and from School questionnaire (BPNS ACS)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Assessment of satisfaction and motivation to active commuting to and from school using the Behavioural Regulation in Active Commuting to and from School questionnaire
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Assessment of self-Esteem and mental health using the Positive and Negative Affect Schedule and the Rosenberg Self-Esteem Scale (RSES)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Children sociodemographic characteristics
Participants self-report their age, school grade and class, gender, full postal address, bicycle owners through a student questionnaire
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Parents sociodemographic characteristics
Parents self-report the school name, child name, age, gender, children´s gender, and full postal address, parental education level through a parents questionnaire
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Family socioeconomic status
Children and parents self-report their family income using the Family Affluence Scale questionnaire (FAS III)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Change of parental perceptions
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)
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Distance home-school-home
Assessment of the route characteristics using Google Maps and GPS
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Weather
Assessment of the Temperature (maximum, minimum, mean), total rainfall, and mean wind speed using data from the National Weather Data Bank
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Assessment of the school enrolment by electronic and manual search
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Assessment of the school socioeconomic status using Geographical Information System
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Assessment of the school engagement using data from the Ministry of Education and Vocational Training
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
City characteristics
Assessment of the population density and city income using data from the Tax Agency, Spanish Public Ministry of Finance and Public Administration of Spain
Measured: 8 weeks during both measurement points (Baseline and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Feb 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, University of Jaén, Navarra Institute for Health Research, Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, University of Otago
- Responsible party
- Principal investigator, Emilio Villa González, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414668
- Sponsor's protocol ID
- ENERGYCO
- Acronym
- ENERGYCO
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENERGY Expenditure of COmmuting to School
- ClinicalTrials.gov ID
- NCT06414668
- Acronym / sponsor ID
- ENERGYCO / ENERGYCO
- Conditions
- Energy Expenditure, Physical Activity, Behavior, Body Composition
- Keywords
- Resting metabolic rate, Energy expenditure, Physical activity, Body composition, Cycling, School
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, University of Jaén, Navarra Institute for Health Research, Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, University of Otago
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling group | Experimental | Behavioral: Cycling Intervention GroupThe 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 |
| Control group | No intervention | –The control group will keep their usual mode of commuting to and from school. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling Intervention GroupA 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. | Behavioural | Cycling group |
Primary outcome
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)
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)
24 secondary outcomes
Change of Physical activity levels
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Heart rate monitoring
Time frame: During the 8 weeks when the participant will cycle to and from school
Resting heart rate monitoring
Time frame: First weekend of the school-based cycling intervention
Cycling skill assessment: Bikeability sessions
Time frame: First week of the school-based cycling intervention
Change of physical fitness
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of physical literacy
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of anthropometric measures
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of anthropometric measures
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of body composition
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of cognitive determinants
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of perceptions to active commuting to and from school
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change in children's psychosocial variables
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Children sociodemographic characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Parents sociodemographic characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Family socioeconomic status
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Change of parental perceptions
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Distance home-school-home
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Weather
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
School characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
City characteristics
Time frame: 8 weeks during both measurement points (Baseline and post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling Intervention Group in people with Energy Expenditure and Physical Activity, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the resting metabolic rate (time frame: 8 weeks during both measurement points (Baseline and post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.