NCT03983447.
Methods |
Type of trial: efficacy Allocation: cluster‐randomised Intervention model: parallel assignment Masking: single (investigator) |
Participants |
Estimated number of schools: 2 Estimated number of students: 352 Inclusion criteria (schools): ‐ Exclusion criteria (schools): ‐ Inclusion criteria (students): 5 to 13 years Exclusion criteria (students): physical diseases that prevent PA |
Interventions |
Intervention: physical (environmental) adaptation of playground, time adaptation of lunch breaks, curriculum‐based programme, workshops and newsletters for parents, meetings for teachers Comparator: no change to school |
Outcomes |
Primary outcome: physical activity, sedentary time Secondary outcomes: anthropometry, parental information, standing broad jump, plate tapping test, shuttle run, cardiorespiratory fitness, academic achievement, attention Other outcomes: ‐ |
Reason for awaiting classification | Listed as 'complete' in ClinicalTrials.gov, but no results published |
Stated aim of 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 socioecological 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, attention abilities and academic achievement. 3)To real ise 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)" |
Notes |