NCT05789693

Brief Summary

The goal of this study is to design, adapt and implement a strategies and a teaching intervention programme to improve the adolescents physical activity in a little city of Spain, in an educational context. Students will be divided in two groups (control and intervention) and we will apply in the intervention in one group and we will develop different strategies aimed at improve the active lifestyles in the adolescents. Researchers will compare both groups taking in to account: levels of physical activity, sedentary time, healthy diet, self-concept or different psychosocial outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 3, 2023

Last Update Submit

March 29, 2023

Conditions

Keywords

Physical activity

Outcome Measures

Primary Outcomes (3)

  • Physical activity and sedentary time (objectively)

    ActiGraph accelerometer

    4 months

  • Physical activity and sedentary time (subjectively)

    Questionnaire: Youth Activity Profile - Spain Likert scale (worst score) 0-4 (best score)

    4 months

  • Future intention to practice physical activity

    Questionnaire: Ad-hoc questions about Theory of Planned Behaviour Likert scale (worst score) 1-7 (best score)

    4 months

Secondary Outcomes (3)

  • Healthy and unhealthy nutrition

    4 months

  • Self-concept

    4 months

  • Motivation to do exercise

    4 months

Study Arms (2)

Intervention

EXPERIMENTAL

Physical activity changes expected Description: * Develop four sessions in the Tutorial Action Plan of the school * Connect several subjects aligned with the messages from the tutory * Physical education teachers provide some insights about healty behaviours

Behavioral: Physical activity changes

No intervention

NO INTERVENTION

No Physical activity changes expected Descrption: \- No intervention

Interventions

Previously an initial measure (qualitative and qualitative) will be made to know the little active adolescents. At the end of the physical activity program a retention measure will be carried out to know the scope and persistence of the variables analyzed. The intervention will be developed with a frequency of three weekly sessions, of 60 minutes, in the period of the intervention, with the exception of weeks in which there is a public holiday, where there will take measures to recover the class. A schedule for the sessions will be set according to the interests of the participants and will be the same for all.

Also known as: Promote active lifestyles, Physical activity in adolescents
Intervention

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age
  • Not participating in a weight loss programme
  • Provide informed consent by parents, mothers or legal guardians
  • Participants must be capable and willing to provide consent
  • Participants must attend at least 80% of the sessions.

You may not qualify if:

  • Unwillingness to either complete the study requirements or to be randomized into control or training group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisham

Huesca, 22001, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 29, 2023

Study Start

February 1, 2022

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations