The ENERGYCO Study

Physical Activity Clinical Trial

— ENERGYCO  

Official title:

ENERGY Expenditure of COmmuting to School

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414668
• Other study ID #: ENERGYCO
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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., 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Behavior
• Body Composition
• Energy Expenditure
• Physical Activity

Intervention

Behavioral:
• Cycling Intervention Group
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.

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the resting metabolic rate	Assessment of the resting metabolic rate using indirect calorimetry (Ominical)	8 weeks during both measurement points (Baseline and post-intervention)
Primary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Change of Physical activity levels	Assessment of the physical activity levels using accelerometry and the "Youth Physical Activity Profile" questionnaire	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Heart rate monitoring	Assessment of the intensity of the commuting by bike to and from school using a pulsometer	During the 8 weeks when the participant will cycle to and from school
Secondary	Resting heart rate monitoring	Assessment of the resting heart rate using a pulsometer	First weekend of the school-based cycling intervention
Secondary	Cycling skill assessment: Bikeability sessions	Assessment of the cycling skills in a closed circuit	First week of the school-based cycling intervention
Secondary	Change of physical fitness	Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope )	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Change of anthropometric measures	Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Change of anthropometric measures	Assessment of waist and neck circumference in centimeters	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Change of cognitive determinants	Assessment of subjective norm, intention, perceived behavioral control and attitude using Questionnaire stages of change	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Children sociodemographic characteristics	Participants self-report their age, school grade and class, gender, full postal address, bicycle owners through a student questionnaire	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Family socioeconomic status	Children and parents self-report their family income using the Family Affluence Scale questionnaire (FAS III)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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)	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Distance home-school-home	Assessment of the route characteristics using Google Maps and GPS	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	Weather	Assessment of the Temperature (maximum, minimum, mean), total rainfall, and mean wind speed using data from the National Weather Data Bank	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	School characteristics	Assessment of the school enrolment by electronic and manual search	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	School characteristics	Assessment of the school socioeconomic status using Geographical Information System	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	School characteristics	Assessment of the school engagement using data from the Ministry of Education and Vocational Training	8 weeks during both measurement points (Baseline and post-intervention)
Secondary	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	8 weeks during both measurement points (Baseline and post-intervention)