- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942431
REBIRTH Active School 2.0 . A School Based Physical Activity Program (RAS2)
REBIRTH Active School 2.0. Impact of a School-based Physical Activity Program on the Long-term Improvement of Student Health.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denise Homeyer, MSc.
- Phone Number: 9114 +49 511 532
- Email: homeyer.denise@mh-hannover.de
Study Contact Backup
- Name: Jeannine von der Born, Dr. med
- Phone Number: 9064 +49511532
- Email: vonderBorn.Jeannine@mh-hannover.de
Study Locations
-
-
Lower Saxony
-
Hanover, Lower Saxony, Germany, 30625
- Recruiting
- Hanover Medical School
-
Contact:
- Denise PI Homeyer, MSc.
- Phone Number: 9114 +49 511532
- Email: homeyer.denise@mh-hannover.de
-
Contact:
- Jeannine von der Born, Dr. med.
- Email: vonderBorn.Jeannine@mh-hannover.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 2nd grade pupils at primary schools (District Hannover/Wolfsburg/Helmstedt/Gifhorn; Lower-Saxony, Germany),
Exclusion Criteria:
- none, if no medical contraindications against intensive physical activity/tests excist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Interventiongroup
60 min per day school based Physical activity program (for one year)
|
60 Minutes of physical activity per day integrated in every school-day.
|
NO_INTERVENTION: Waitinggroup
Intervention starts after one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Endurance capacity via Six-Minutes Running test
Time Frame: At baseline, after 1 and 2 years.
|
Completed meters in Six-Minutes running test: German Motor Test 6-18 (Bös, 2009):
|
At baseline, after 1 and 2 years.
|
Change in Sprint velocity via 20 meter sprint
Time Frame: At baseline, after 1 and 2 years.
|
20 meter sprint test measured in seconds: German Motor Test 6-18 (Bös, 2009).
Scoring the best attempt out of two.
|
At baseline, after 1 and 2 years.
|
Change in Strength tests via 40 seconds of Push ups and sit ups
Time Frame: At baseline, after 1 and 2 years.
|
Number of repetitions in 40 seconds of Push ups and sit ups: German Motor Test 6-18 (Bös, 2009)
|
At baseline, after 1 and 2 years.
|
Change in Coordination exercise: via 60 seconds Single leg stand
Time Frame: At baseline, after 1 and 2 years.
|
Ground contacts in 60 seconds Single leg stand: German Motor Test 6-18 (Bös, 2009)
|
At baseline, after 1 and 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral blood pressure
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Central blood pressure
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Arterial pulse wave
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Quality of life via KidKindl
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Physical activity questionnaire
Time Frame: At baseline, after 1 and 2 years.
|
The physical activity will be assessed applying the physical activity questionnaire according to the KIGGS Study (MoMo Modul) in a 1 to 1 interview.
|
At baseline, after 1 and 2 years.
|
BMI (kg/m^2)
Time Frame: At baseline, after 1 and 2 years.
|
weight and height will be combined to report BMI in kg/m^2
|
At baseline, after 1 and 2 years.
|
Body Fat Mass (kg), (%)
Time Frame: At baseline, after 1 and 2 years.
|
Body Fat Mass will be measured in kilogram and percent via Body Impedance Measurement using the InBody 230.
|
At baseline, after 1 and 2 years.
|
Skeletal Muscle Mass (kg)
Time Frame: At baseline, after 1 and 2 years.
|
Skeletal Muscle Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
|
At baseline, after 1 and 2 years.
|
Fat Free Mass (kg)
Time Frame: At baseline, after 1 and 2 years.
|
Fat Free Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
|
At baseline, after 1 and 2 years.
|
Body height (cm)
Time Frame: At baseline, after 1 and 2 years.
|
Measured in cm
|
At baseline, after 1 and 2 years.
|
Waist - Hip circumferences (cm)
Time Frame: At baseline, after 1 and 2 years.
|
Measured in cm
|
At baseline, after 1 and 2 years.
|
Concentration ability
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Pediatric Quality of Life
Time Frame: At baseline, after 1 and 2 years.
|
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.
|
At baseline, after 1 and 2 years.
|
Cognitive function
Time Frame: At baseline, after 1 and 2 years.
|
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)
|
At baseline, after 1 and 2 years.
|
Dental health Status
Time Frame: At baseline, after 1 and 2 years.
|
Dental health status will be assessed via questionnaire (6 Questions) in a 1 to 1 interview.
|
At baseline, after 1 and 2 years.
|
Program adherence
Time Frame: Whole intervention period (24 month)
|
Program adherence will be assessed via Protocols by documenting the number of physical activity impulses at each participating school (minutes per day).
|
Whole intervention period (24 month)
|
Phosphat (mmol/l)
Time Frame: At baseline, after 1 and 2 years.
|
Phosphat in mmol/l will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
CysC; Cystatin C (mg/l)
Time Frame: At baseline, after 1 and 2 years.
|
CysC in mg/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Urea (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Urea in mg/dl will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Kreatinin (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Kreatinin in mg/dl will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Uric acid (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Uric acid in mg/dl will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
GPT; Glutamate pyruvate transaminase (U/l)
Time Frame: At baseline, after 1 and 2 years.
|
GPT in U/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Bilirubin (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Bilirubin in mg/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Triglyceride (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Triglyceride in mg/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Albumin (g/l)
Time Frame: At baseline, after 1 and 2 years.
|
Albumin in g/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
CRPhs; High-sensitivity C-reactive protein (mg/l)
Time Frame: At baseline, after 1 and 2 years.
|
CRPhs in mg/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
HbA1c (%)
Time Frame: At baseline, after 1 and 2 years.
|
HbA1c in % will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
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Cortisol (µg/l),
Time Frame: At baseline, after 1 and 2 years.
|
Cortisol in µg/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Insulin (U/l )
Time Frame: At baseline, after 1 and 2 years.
|
Insulin in U/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Leukozyten (Tsd/µl)
Time Frame: At baseline, after 1 and 2 years.
|
Leukozyten in Tsd/µl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Erythrozyten (Mio/µl)
Time Frame: At baseline, after 1 and 2 years.
|
Erythrozyten in Mio/µl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Hb; Hemoglobin (g/dl),
Time Frame: At baseline, after 1 and 2 years.
|
Hb in g/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Hkt;hematocrit (%)
Time Frame: At baseline, after 1 and 2 years.
|
Hkt in %, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
MCHC ean corpuscular hemoglobin concentration (g/dl)
Time Frame: At baseline, after 1 and 2 years.
|
MCHC in g/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Thrombozyten (Tsd/µl)
Time Frame: At baseline, after 1 and 2 years.
|
Thrombozyten in Tsd/µl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Natrium (mmol/l)
Time Frame: At baseline, after 1 and 2 years.
|
Natrium in mmol/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Kalium (mmol/l)
Time Frame: At baseline, after 1 and 2 years.
|
Kalium in mmol/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Calcium (mmol/l)
Time Frame: At baseline, after 1 and 2 years.
|
Calcium in mmol/l, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Cholesterin (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
Cholesterin in mg/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
HDL; High Density Lipoprotein (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
HDL in mg/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
LDL; Low Density Lipoprotein (mg/dl)
Time Frame: At baseline, after 1 and 2 years.
|
LDL in mg/dl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
MCV; mean corpuscular volume (fl)
Time Frame: At baseline, after 1 and 2 years.
|
MCV in fl, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
MCH; mean corpuscular hemoglobin (pg)
Time Frame: At baseline, after 1 and 2 years.
|
MCH in pg, will be measured via Blood Analysis.
Blood will be taken in the morning with a fasting blood test.
|
At baseline, after 1 and 2 years.
|
Urine Analysis
Time Frame: At baseline, after 1 and 2 years.
|
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)
|
At baseline, after 1 and 2 years.
|
Salvia Analysis
Time Frame: At baseline, after 1 and 2 years.
|
salvia
|
At baseline, after 1 and 2 years.
|
Steps per day
Time Frame: At baseline, after 1 and 2 years.
|
Steps per day will be assessed via Garmin Vivofit 4 devices.
|
At baseline, after 1 and 2 years.
|
Hours of sleep
Time Frame: At baseline, after 1 and 2 years.
|
Hours of sleep will be assessed via Garmin Vivofit 4 devices.
|
At baseline, after 1 and 2 years.
|
Metabolic Equivalent
Time Frame: At baseline, after 1 and 2 years.
|
Metabolic Equivalent (MET) (1 kcal/kg/hour) will be assessed applying Garmin Vivofit 4 devices.
|
At baseline, after 1 and 2 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uwe Tegtbur, Prof. Dr. med., Hannover Medical School, Hannover Lower Saxony, Germany, 30625
- Principal Investigator: Anette Melk, Prof. Dr. med., Hannover Medical School, Hannover Lower Saxony, Germany, 30625
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 7290
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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