NCT03974607

Brief Summary

The main objective of the research project presented is to improve physical activity levels in adolescents who present rates of diagnosed active impairment through the design, development and evaluation of a multidisciplinary intervention program of physical activity to promote healthier lifestyles . This program will follow the principles of the Theory of Self-determination, using Information and Communication Technologies (ICTs), a training plan for monitors, teachers and parents, with the aim of achieving greater adherence to the sports practice of adolescents from Extremadura, with the benefits at a psychosocial, cognitive and biological level that this entails.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

August 20, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

May 22, 2019

Last Update Submit

August 19, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • Perception of physical activity levels

    The levels of PA of adolescents were assessed using a scale designed by the WHO and developed in many countries called the International Physical Activity Questionnaire (IPAQ - A: Hagströmer et al., 2008).

    3 Months

  • Type of motivation towards sports

    The motivation of the students will be evaluated when doing physical exercise through the versioned Spanish version (BREQ-2: Moreno-Murcia Cervelló, and Martínez, 2007) of the Behavioral Regulation in Exercise Questionnaire (BREQ-3: Wilson Rodgers, Loitz , and Scime, 2006).

    3 Months

  • Satisfaction of basic psychological needs: scale

    The perception of body image and the desired body image of the students will be analyzed, using the scale of Stunkard, Sørensen, and Schulsinger (1983).

    3 Months

  • Levels of physical activity

    The level of physical activity will be measured with Actigraph wGT3X-BT accelerometers will be used, with high reliability and information storage capacity.

    3 Months

  • Body Image Dimensional Assessment

    The dimension of the body image of adolescents will be analyzed with the BIDA questionnaire (Segura-García et al., 2012).

    3 Months

  • Physical condition

    The physical condition (strength, endurance and agility) will be evaluated by the Alpha Fitness test battery (Ruiz et al., 2011).

    4 Months

  • Body composition

    The body fat percentage will be assessed through the subscapular and triciple pligues using the Holtain plicter.

    4 Months

  • Body Mass Index (BMI)

    The BMI of the participants will be evaluated. To do this, all young students will be measured and weighed and the BMI calculated using the following formula: BMI = Weight (Kg) / Height2 (Mt). For this, the Scale (SECA 877), and a Leicester Height Measure brand stadiometer, Marsden Group, will be used.

    4 Months

Study Arms (2)

Physical Activity

EXPERIMENTAL

Physical Activity Programme (PAP) was planned for the promotion of PA and other healthy habits in inactive adolescents as an agent of change intervention, in which a trained staff actively disseminates effective practices to improve the PA's habits of adolescents.

Behavioral: Physical Activity Program (PAP)

No Physical Activity

NO INTERVENTION

The control group will be selected in a targeted manner according to the availability of the center. You will not be given any information about healthy habits nor will any physical training program be applied to you, so that you do not give indications that may produce a variation of your habitual behavior.

Interventions

A Physical Activity Program (PAP) will be carried out. Previously an initial measure will be made to know the little active adolescents. At the end of the PAF a retention measure will be carried out to know the scope and persistence of the variables analyzed. The PAF 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 we 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. During the sessions, basic physical abilities and motor skills will be worked on with playful proposals focused on the improvement of physical and psychosocial parameters. They will always have the same monitor Graduate in Physical Activity and Sports Sciences, which will be responsible for developing the PAF.

Physical Activity

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: 10 - 16 años
  • Nor engaged in regular physical activity \> 20 min on \> 3 days/week
  • Not participating in a weight loss programme
  • Provide informed consent by parents, mothers or legal guardians

You may not qualify if:

  • Participants must attend at least 80% of the sessions.
  • 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)

Pedro Antonio Sánchez Miguel

Cáceres, Extremadura, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pedro Antonio Sánchez Miguel

    University Extremadura

    STUDY DIRECTOR
  • Miguel Angel Tapia Serrano

    University Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2019

First Posted

June 5, 2019

Study Start

May 1, 2018

Primary Completion

January 21, 2020

Study Completion

July 28, 2020

Last Updated

August 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations