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School Intervention to Promote Physical Activity and Reduce the Sedentary Time of Low-income Children Aged 6-13 Years

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ClinicalTrials.gov Identifier: NCT03983447
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pau and Pays de l'Adour

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE November 1, 2016
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Physical Activity (PA) [ Time Frame: 7 days ]
    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.
  • Sedentary Time (ST) [ Time Frame: 7 days ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Anthropometry: Body Mass Index (BMI) [ Time Frame: 10 minutes for each child ]
    Units : kg/m^2.The weight and height of the children were measured just prior of this test, in each measurement period
  • Subjective information about family and child [ Time Frame: 20 minutes ]
    Parents participating in the project were asked to complete a questionnaire to obtain some information: age and gender of the child; socioeconomic data measured by the four-item scale "Family Affluence Scale II" (FAS II) (Boyce, Torsheim, Currie et Zambon, 2006). FAS II: 4 item-scale that asks families how many "car/bedrooms/computers" they have and how often they go on holiday. A composite FAS score is calculated for each family summing up the responses to these four items. The sample is then categorised using a three-point ordinal scale where low FAS (score=0,1,2) indicates low affluence, medium FAS (score=3,4,5) indicates medium affluence, and high FAS (score=6,7,8,9) indicates high affluence (Aibar, 2012) ; parental perception of the competence of their children in physical activity practice; sedentary behaviour of the child (time spent playing video games, wa
  • Standing broad jump (Motor Skills) [ Time Frame: 2 hours for each grade ]
    Units : cm. The test was realized for all children from grade 1 to 5 in a two-hour physical education class. This test of the Eurofit battery measures power and inter-segmental coordination. He stands behind a starting line and jump by throwing his arms forward. Three trials are allowed and only the best performance is analysed.
  • Plate tapping test (Motor Skills) [ Time Frame: 2 hours for each grade ]
    Units : seconds.The assessment of this test was realized for all children from grade 1 to 5 in a two-hour physical education class. The speed and coordination of the upper limbs is measured. The child is situated in from of a table. Two rubber discs 20 cm in diameter are fixed horizontally on the table, with a gap of 60 cm. A rectangular plate is placed between the two discs. The child puts a hand in the middle of the rectangular plate and touches the discs alternatively as quickly as possible with the other hand, passing over the hand situated in the middle. He performs 25 cycles.
  • 6 x 5m Shuttle Run (Motor Skills) [ Time Frame: 2 hours for each grade ]
    Units: seconds.This test was realized for all children from grade 1 to 5 in a two-hour physical education class.This test was adapted from the 10x5m shuttle test of the Eurofit battery. It measures the speed-coordination of inter-segmental limbs. The specialist evaluates the time needed to cover the distance with a stopwatch.
  • Cardiorespiratory fitness: 20m shuttle run test [ Time Frame: 2 hours for each grade ]
    Units: seconds.The assessment of motor skills was realized for all children from grade 1 to 5 in a two-hour physical education class.The aerobic capacity of the children was measured with an adapted version of the 20m shuttle run test (Cadenas Sanchez, 2011). The initial speed is reduced at 6.5 km/h and increase according to the laps and the stage numbers.
  • Academic achievement [ Time Frame: 1 hour for each grade ]
    Units : %. The learning achievement for children from grade 1 to 5 was collected at the beginning of the school year. The percentages of success rate of "reading", "spelling" and "mathematics" were collected.
  • Attention [ Time Frame: 10 minutes for each child ]
    Units : % and seconds.The computer-based modified Erickson Flanker Task was used (Have et al, 2016). It was designed with the software Superlab 4.5 (AD instruments) by the researcher specialist. This test is a variant version of the classing Flanker-Task (Eriksen et Ericksen, 1974). It permits the measurement of inhibition and cognitive flexibility, which are identified as executive functions and specifically attentional abilities.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School Intervention to Promote Physical Activity and Reduce the Sedentary Time of Low-income Children Aged 6-13 Years
Official Title  ICMJE School Intervention to Promote Physical Activity and Reduce the Sedentary Time of Low-income Children Aged 6-13 Years
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).

Detailed Description

Physical activity (PA) has decreased drastically in the 21st century in developed and industrialized societies. In 2009, 23.3% of the world's population did not comply with WHO's recommendations for physical activity, reaching real levels of pandemic. Technological advances have contributed to the emergence of new leisure activities, which may preclude the participation in PA and encourage sedentary behaviours. However, it is now well known that PA has numerous benefits on physical, psychological and social health. Thus, promoting PA becomes a necessity for adults and even more for children since healthy habits that are adopted during childhood will last throughout life and predict adult health. Hence, for this last population, 60 minutes of moderate-to-vigorous physical activity (MVPA) per day are recommended in public health guidelines.

A recent project named "Capas-Cité", created in 2012 in Tarbes (France) and in Zaragoza (Spain) realize PA programs and promotion actions that have a beneficial impact on health. These two similar cities have been selected for their geographical proximity and their similarity. These programs are included in research work carried out by the University of Tarbes and the University of Zaragoza that focus on the promotion of PA. "Capas-Cité" project aims to improve the health of disadvantaged population.

The two primary schools (School A and School B) located in the disadvantaged neighbourhood of Tarbes were contacted to participate in the study. Both schools include children from grade 1 (6 years old) to grade 5 (10 years old). They have never benefited from intervention programs on the field of PA and agreed to participate in the project.

During the academic year 2016/2017, baseline assessments were carried out in the two French schools: measures of PA, ST, motors skills, attentional abilities and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). The measures of attentional abilities involve only children in 2nd, 3th and 4th grade. Children in both schools had to have parental permission to participate in PA, ST and attentional abilities measurements. Motor skills were assessed for all the children at school and their academic achievement were collected.

During the academic school year 2017/2018, School A benefited of an intervention to increase PA and reduce ST. This intervention program involves all the children from grade 1 to grade 5 without parental permission. Families are not required to contribute financially participation in this project. During this intervention year, the same periods of assessment as those carried at baseline were repeated in November/December 2017 (T3) and May/June 2018 (T4). These repeated assessment time provide a first overview of the efficiency of the intervention. The school B has the intervention program during the school year 2018/2019.

Accelerometers were used to measure PA and ST. Accelerometry is a reliable and valid objective to measure PA and ST. Children should wear the accelerometer on the right side of the hip, adjusted with an elastic belt.

In Spain, only observational measures were realised. . A total of 179 children have worn accelerometers for a week. PA and ST were analysed for week end days on one hand and on the other hand according to different periods of time for weekdays: the time before school, lunch, after school and at night.54.97% of the children complied with the MVPA guidelines all days of the week. MVPA represented 67.70±17.83 min.day-1 and ST was 606.14±37.39 min.day-1 for the total sample.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Physical Activity
  • Sedentary Behavior
  • Children
  • School-based Intervention
Intervention  ICMJE Behavioral: School-based intervention to promote PA and reduce ST

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
Study Arms  ICMJE
  • Experimental: School-based intervention to promote Physical Activity (PA)

    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
    Intervention: Behavioral: School-based intervention to promote PA and reduce ST
  • No Intervention: Control
    Nothing has changed in the school.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
350
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Physical diseases that prevent PA practice
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983447
Other Study ID Numbers  ICMJE UPPA (University of Pau)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Pau and Pays de l'Adour
Study Sponsor  ICMJE University of Pau and Pays de l'Adour
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pau and Pays de l'Adour
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP