NCT06414668

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

May 6, 2024

Last Update Submit

December 3, 2024

Conditions

Energy ExpenditurePhysical ActivityBehaviorBody Composition

Keywords

Resting metabolic rateEnergy expenditurePhysical activityBody compositionCyclingSchool

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (24)

  • Change of Physical activity levels

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

  • Heart rate monitoring

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

  • Resting heart rate monitoring

    First weekend of the school-based cycling intervention

  • Cycling skill assessment: Bikeability sessions

    First week of the school-based cycling intervention

  • Change of physical fitness

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

  • +19 more secondary outcomes

Study Arms (2)

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

Behavioral: Cycling Intervention Group

Control group

NO INTERVENTION

The control group will keep their usual mode of commuting to and from school.

Interventions

Cycling Intervention GroupBEHAVIORAL

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.

Cycling group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Motor ActivityBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 16, 2024

Study Start

February 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

ES(1)