Rebirth active SCHOOL 2.0 is a physical activity intervention program and about to be realised at 40 primary schools in Lower Saxony Germany. Half of all schools will be assigned to the intervention program or to wait for one year before starting with the movement program. After one and two years, the follow up will take place. After completing baseline examinations (i.e. physical and cognitive functions, physical activity questionnaires) the intervention program will start for one year. The intervention program is going to be designed with the goal of implementing physical activity of 60 minutes per day. For the main module of movement impulses, the pupils will perform a 5-minute exercise in every lesson, realised by the teachers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,245
60 Minutes of physical activity per day integrated in every school-day.
Hanover Medical School
Hanover, Lower Saxony, Germany
Change in Endurance capacity via Six-Minutes Running test
Completed meters in Six-Minutes running test: German Motor Test 6-18 (Bös, 2009):
Time frame: At baseline, after 1 and 2 years.
Change in Sprint velocity via 20 meter sprint
20 meter sprint test measured in seconds: German Motor Test 6-18 (Bös, 2009). Scoring the best attempt out of two.
Time frame: At baseline, after 1 and 2 years.
Change in Strength tests via 40 seconds of Push ups and sit ups
Number of repetitions in 40 seconds of Push ups and sit ups: German Motor Test 6-18 (Bös, 2009)
Time frame: At baseline, after 1 and 2 years.
Change in Coordination exercise: via 60 seconds Single leg stand
Ground contacts in 60 seconds Single leg stand: German Motor Test 6-18 (Bös, 2009)
Time frame: At baseline, after 1 and 2 years.
Peripheral blood pressure
Peripheral blood pressure will be measured in a seated position after a resting period of 5 minutes. We will use the oscillometric Dinamap device (Dinamap v150; Fa. GE Medical Systems, Chicago, Illinois, USA). Three measurements will be taken on the right and on the left arm. Between each measurement will be a 1 minute resting period. The Median of the left and the right arm is used for further calculations. If the Median is above the 90th percentile three measurements will be taken again by the investigator using the auscultatory method.
Time frame: At baseline, after 1 and 2 years.
Central blood pressure
Central blood pressure will be measured in a spinal position using an oscillometric device, the Mobil-O-Graph (I.E.M. GmbH). The cuff size must be chosen accordingly to the arm size. After a resting period of 5 minutes 3 measurements will be taken on the right arm. Between each measurement will be 30 seconds. The mean of the 3 measurements will be used for further calculations.
Time frame: At baseline, after 1 and 2 years.
Arterial pulse wave
Arterial pulse wave will be measured in a spinal position using the Vicorder. The patient should rest for 5 minutes before the start of the measurement. The thigh cuff will be placed around the patient's upper right thigh as high as possible. The cuff around the neck has to be placed over the right carotid artery. The investigator has to measure from the suprasternal notch vertically to the umbilicus and from the umbilicus diagonally to the mid of the thigh cuff. The length will be added up and the measurement from the suprasternal notch to the cuff around the neck will be subtracted. The length will be used for calculating the arterial pulse wave velocity. Three measurements will be taken with each having 10 consecutive waveforms with similar shape and size. The mean of the 3 measurements will be used for further calculations.
Time frame: At baseline, after 1 and 2 years.
Quality of life via KidKindl
The quality of life will be assessed applying the KidKindl questionnaire (6 questions, Likert-Skale, 24 Items, Scale 0-100) in a 1 to 1 interview. Higher scores mean a better outcome.
Time frame: At baseline, after 1 and 2 years.
Physical activity questionnaire
The physical activity will be assessed applying the physical activity questionnaire according to the KIGGS Study (MoMo Modul) in a 1 to 1 interview.
Time frame: At baseline, after 1 and 2 years.
BMI (kg/m^2)
weight and height will be combined to report BMI in kg/m\^2
Time frame: At baseline, after 1 and 2 years.
Body Fat Mass (kg), (%)
Body Fat Mass will be measured in kilogram and percent via Body Impedance Measurement using the InBody 230.
Time frame: At baseline, after 1 and 2 years.
Skeletal Muscle Mass (kg)
Skeletal Muscle Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
Time frame: At baseline, after 1 and 2 years.
Fat Free Mass (kg)
Fat Free Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
Time frame: At baseline, after 1 and 2 years.
Body height (cm)
Measured in cm
Time frame: At baseline, after 1 and 2 years.
Waist - Hip circumferences (cm)
Measured in cm
Time frame: At baseline, after 1 and 2 years.
Concentration ability
The concentration ability will be assessed via the CCTT (children colour trail test) using the time required to perform the test and mistakes made in the test. Percentiles can be used for the comparison with peers.
Time frame: At baseline, after 1 and 2 years.
Pediatric Quality of Life
Quality of Life will be assessed via PedsQL (Quality of Life via PedsQL), 6 Questions in a 1 to 1 interview. Higher scores refect a higher quality of life.
Time frame: At baseline, after 1 and 2 years.
Cognitive function
Cognitive function (Happiness/Trust/Learning) will be assessed via questionnaire in a 1 to 1 interview (Scale 0-100, a higher score means a better outcome)
Time frame: At baseline, after 1 and 2 years.
Dental health Status
Dental health status will be assessed via questionnaire (6 Questions) in a 1 to 1 interview.
Time frame: At baseline, after 1 and 2 years.
Program adherence
Program adherence will be assessed via Protocols by documenting the number of physical activity impulses at each participating school (minutes per day).
Time frame: Whole intervention period (24 month)
Phosphat (mmol/l)
Phosphat in mmol/l will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
CysC; Cystatin C (mg/l)
CysC in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Urea (mg/dl)
Urea in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Kreatinin (mg/dl)
Kreatinin in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Uric acid (mg/dl)
Uric acid in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
GPT; Glutamate pyruvate transaminase (U/l)
GPT in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Bilirubin (mg/dl)
Bilirubin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Triglyceride (mg/dl)
Triglyceride in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Albumin (g/l)
Albumin in g/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
CRPhs; High-sensitivity C-reactive protein (mg/l)
CRPhs in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
HbA1c (%)
HbA1c in % will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Cortisol (µg/l),
Cortisol in µg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Insulin (U/l )
Insulin in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Leukozyten (Tsd/µl)
Leukozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Erythrozyten (Mio/µl)
Erythrozyten in Mio/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Hb; Hemoglobin (g/dl),
Hb in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Hkt;hematocrit (%)
Hkt in %, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
MCHC ean corpuscular hemoglobin concentration (g/dl)
MCHC in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Thrombozyten (Tsd/µl)
Thrombozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Natrium (mmol/l)
Natrium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Kalium (mmol/l)
Kalium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Calcium (mmol/l)
Calcium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Cholesterin (mg/dl)
Cholesterin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
HDL; High Density Lipoprotein (mg/dl)
HDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
LDL; Low Density Lipoprotein (mg/dl)
LDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
MCV; mean corpuscular volume (fl)
MCV in fl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
MCH; mean corpuscular hemoglobin (pg)
MCH in pg, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Time frame: At baseline, after 1 and 2 years.
Urine Analysis
Urine will be taken from the midstream urine. The children will take the sample with the help of the parents at home. The lab will measure the following urin parameters: Protein, Albumin (mg/dl), Kreatinin (g/l), Osmolarität (mOsm/kg)
Time frame: At baseline, after 1 and 2 years.
Salvia Analysis
salvia
Time frame: At baseline, after 1 and 2 years.
Steps per day
Steps per day will be assessed via Garmin Vivofit 4 devices.
Time frame: At baseline, after 1 and 2 years.
Hours of sleep
Hours of sleep will be assessed via Garmin Vivofit 4 devices.
Time frame: At baseline, after 1 and 2 years.
Metabolic Equivalent
Metabolic Equivalent (MET) (1 kcal/kg/hour) will be assessed applying Garmin Vivofit 4 devices.
Time frame: At baseline, after 1 and 2 years.
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