|- candidate number||22477|
|- NTR Number||NTR5310|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jul-2015|
|- Secondary IDs||2014-59 Ethische Commissie Bewegingswetenschappen|
|- Public Title||Intervention of additional physical education lessons|
|- Scientific Title||The effect of doubling physical education lessons on motor skills, physical fitness and BMI in elementary school children.|
|- hypothesis||It is hypothesized that gross motor skills levels will increase and fine motor skills levels will remain unchanged as a result of the intervention. Also, it is expected that endurance capacity is improved and mean BMI levels are reduced.|
|- Healt Condition(s) or Problem(s) studied||Gross and fine motor skills, Maximal exercise capacity, BMI|
|- Inclusion criteria||1. Children in the 1st grade of elementary school (age 6 & 7 yo).|
2. Four schools participating in this study are selected by the municipality of Amsterdam.
3. Measurements only take place with the absence of objections of children or parents.
|- Exclusion criteria||1. An IQ below 70|
2. Injuries or other physical impairments
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2014|
|- planned closingdate|
|- Target number of participants||220|
|- Interventions||The intervention consists of doubling the time of physical education lessons. The intervention group receives the double amount of physical education lessons than they normally do. Therefore, they receive physical education lessons for 45 minutes, 4 times a week. The control group continues with the usual 45 minutes, 2 times a week. All lessons are given by physical education teachers. The content of the extra lessons is chosen by the local physical education teacher in a way that fits the educational curriculum and matches the motor skills level of the intervention group.|
|- Primary outcome||Motor skills level (gross and fine):
The movement assessment battery for children (MABC-2) will be the instrument for assessing the motor skills level (gross and fine)|
Gross motor skills level:
The Movement Scan (4-skills test, Van Gelder) will be the instrument for assessing gross motor skills.
The 20 meters shuttle run test will be used for assessing endurance capacity
Body Mass Index (BMI):
BMI will be calculated by length and height
|- Secondary outcome||A questionnaire is used to gather information about school characteristics concerning sports facilities in and around school. Also the socio economic status (SES) at school level will be collected to be able to control for the variables.|
|- Timepoints||Minimal 18 months|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||drs. Tim van Kernebeek|
|- CONTACT for SCIENTIFIC QUERIES||dr. Huub Toussaint|
|- Sponsor/Initiator ||Hogeschool van Amsterdam, Domein Sport, Bewegen en Voeding, Afdeling Academie voor Lichamelijke Opvoeding (ALO), Gemeente Amsterdam|
(Source(s) of Monetary or Material Support)
|Hogeschool van Amsterdam, Domein Sport, Bewegen en Voeding, Afdeling Academie voor Lichamelijke Opvoeding (ALO), Gemeente Amsterdam|
|- Brief summary||Rationale: |
Last few decades, both physical activity levels and motor skills levels have declined. Since motor development is an important part of the healthy development of children and is stimulated through a fitting physical education curriculum at school, acquisition of motor skills at young age is of main importance for a healthy and active life style, now and in the future.
The aim of this study is to determine the effects of a doubling in physical education lessons on (gross) motor skills, endurance capacity and BMI in elementary school children.
A two arms, non-randomized controlled trial (quasi-experimental design) will be done to determine the effectiveness of the intervention. After baseline measurements, repeated measurements take place every 6 months for at least 18 months. Follow-up measurements will be conducted one year after the intervention.
Children in the 1st grade of elementary schools in Amsterdam.
The intervention consists of doubling the time of physical education lessons to 45 minutes, 4 times a week.
Main study parameters/endpoints:
The effects on (gross) motor skills, endurance capacity and BMI will be studied.
|- Main changes (audit trail)|
|- RECORD||17-jul-2015 - 20-aug-2015|