NCT03983447

Brief Summary

This study is realized in 2 primary schools in the city of Tarbes (France), located in a disadvantaged neighbourhood : 352 children are included in the study. This study has many goals: 1) to propose an intervention to promote PA (Physical Activity) and reduce ST (Sedentary Time) of children aged 6 to 13 years from a primary school located in a disadvantaged neighbourhood and measures the effectiveness of this intervention (1rst grade-5th grade). This intervention was based on the factors of socio-ecological model related to health behaviours. The levels of PA and ST of the experimental school will be compared to a control school with the realization of pre and post intervention measures. 2) To study the relationships between PA, ST, motors skills, attentional abilities and academic achievement. 3)To realise a descriptive analysis of PA and ST of children in 2nd and 5th grade from France and Spain (observational study). For this goal, an other school in Spain was included in the study (city of Huesca, 60 children).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 3, 2019

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physical Activity (PA)

    Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of PA. Accelerometry is a reliable and valid objective to measure PA.

    7 days

  • Sedentary Time (ST)

    Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of ST. Accelerometry is a reliable and valid objective to measure ST.

    7 days

Secondary Outcomes (8)

  • Anthropometry: Body Mass Index (BMI)

    10 minutes for each child

  • Subjective information about family and child

    20 minutes

  • Standing broad jump (Motor Skills)

    2 hours for each grade

  • Plate tapping test (Motor Skills)

    2 hours for each grade

  • 6 x 5m Shuttle Run (Motor Skills)

    2 hours for each grade

  • +3 more secondary outcomes

Study Arms (2)

School-based intervention to promote Physical Activity (PA)

EXPERIMENTAL

This intervention included : 1. Physical (Environmental) adaptation of playground 2. Time adaptation of lunch breaks 3. Curriculum-based program of children 4. Workshops and newsletters for parents 5. Meetings for teachers

Behavioral: School-based intervention to promote PA and reduce ST

Control

NO INTERVENTION

Nothing has changed in the school.

Interventions

This intervention was realized with all the children (1st grade-5th grade) and involved : 1. Physical (Environmental) adaptation of playgrounds 2. Time adaptation of lunch breaks 3. Curriculum-based program for children 4. Workshops and newsletters for parents 5. Meetings for teachers

School-based intervention to promote Physical Activity (PA)

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children (girls, boys) aged 5-13 years old

You may not qualify if:

  • Physical diseases that prevent PA practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Aibar A, Bois JE, Generelo E, Zaragoza Casterad J, Paillard T. A cross-cultural study of adolescents' physical activity levels in France and Spain. Eur J Sport Sci. 2013;13(5):551-8. doi: 10.1080/17461391.2012.746733. Epub 2012 Nov 23.

    PMID: 24050473BACKGROUND
  • Kriemler S, Meyer U, Martin E, van Sluijs EM, Andersen LB, Martin BW. Effect of school-based interventions on physical activity and fitness in children and adolescents: a review of reviews and systematic update. Br J Sports Med. 2011 Sep;45(11):923-30. doi: 10.1136/bjsports-2011-090186.

    PMID: 21836176BACKGROUND
  • Hartmann T, Zahner L, Puhse U, Puder JJ, Kriemler S. Effects of a school-based physical activity program on physical and psychosocial quality of life in elementary school children: a cluster-randomized trial. Pediatr Exerc Sci. 2010 Nov;22(4):511-22. doi: 10.1123/pes.22.4.511.

    PMID: 21242601BACKGROUND
  • Rhodes RE, Janssen I, Bredin SSD, Warburton DER, Bauman A. Physical activity: Health impact, prevalence, correlates and interventions. Psychol Health. 2017 Aug;32(8):942-975. doi: 10.1080/08870446.2017.1325486. Epub 2017 May 30.

    PMID: 28554222BACKGROUND
  • Scudder MR, Lambourne K, Drollette ES, Herrmann SD, Washburn RA, Donnelly JE, Hillman CH. Aerobic capacity and cognitive control in elementary school-age children. Med Sci Sports Exerc. 2014;46(5):1025-35. doi: 10.1249/MSS.0000000000000199.

    PMID: 24743109BACKGROUND
  • Khan NA, Hillman CH. The relation of childhood physical activity and aerobic fitness to brain function and cognition: a review. Pediatr Exerc Sci. 2014 May;26(2):138-46. doi: 10.1123/pes.2013-0125. Epub 2014 Apr 10.

    PMID: 24722921BACKGROUND
  • Bernal CMM, Lhuisset L, Fabre N, Bois J. School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e17815. doi: 10.2196/17815.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: During the academic year 2016/2017, baseline assessments were carried out in two schools (school A, school B): measures of PA, ST, motors skills, attentional capacity and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). During the academic school year 2017/2018, a school-based intervention to increase PA and reduce ST was realised in School A (measure in November 2017 and May/June 2018). Finally, during the academic school year 2018/2019, a school-based intervention to increase PA and reduce ST was realised in School B (measure only in May/June 2019).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 12, 2019

Study Start

November 1, 2016

Primary Completion

December 20, 2016

Study Completion

May 31, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06