Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
BMI |
Overweight and obesity will be assessed based on the BMI of the children. |
Between October 2021 and January 2022 |
|
Primary |
zBMI |
zBMI will be calculated using German and WHO growth curves / distributions for evaluating child weight status. |
Through study completion, an average of 4 months |
|
Secondary |
Body weight in kg |
Body weight in kg during the study visit at schools |
Between October 2021 and January 2022 |
|
Secondary |
Height in cm |
Height in cm during the study visit at schools |
Between October 2021 and January 2022 |
|
Secondary |
abdominal circumference in cm |
abdominal circumference in cm during the study visit at schools |
Between October 2021 and January 2022 |
|
Secondary |
Upper arm circumference in cm |
Upper arm circumference in cm during the study visit at schools |
Between October 2021 and January 2022 |
|
Secondary |
Body weight at the time of the U8 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
Height at the time of the U8 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
BMI at the time of the U8 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
Body weight at the time of the U9 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
Height at the time of the U9 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
BMI at the time of the U9 physical examination |
U-Examinations are standard physical examinations available to all children in Germany at pre-specified timepoints. The results of these is recorded in special booklets, kept by the parents. |
Between October 2021 and January 2022 |
|
Secondary |
Body weight S1 examination data |
The S1 examination is an examination performed by the health authorities before a child starts goinig to a school. The records are kept by the health authorities. |
Between October 2021 and January 2022 |
|
Secondary |
Height at the time of the S1 examination data |
The S1 examination is an examination performed by the health authorities before a child starts goinig to a school. The records are kept by the health authorities. |
Between October 2021 and January 2022 |
|
Secondary |
BMI at the time of the S1 examination data |
The S1 examination is an examination performed by the health authorities before a child starts goinig to a school. The records are kept by the health authorities. |
Between October 2021 and January 2022 |
|
Secondary |
Eating habits |
Eating habits will be evaluated using a 3-day food record and a questionnaire |
Between October 2021 and January 2022 |
|
Secondary |
Physical activity |
Physical activity will be assessed using a modified PAQ-C questionnaire as well as a questionnaire for parents |
Between October 2021 and January 2022 |
|
Secondary |
Cognitive testing: Distractibility |
Distractibility will be studied by a computer-based test from the KiTAP test battery developed by PSYTEST Psychologische Testsysteme, Herzogenrath, which will be administered to the children. |
Between October 2021 and January 2022 |
|
Secondary |
Cognitive testing: Cognitive flexibility |
Cognitive flexibility will be studied by a computer-based test from the KiTAP test battery developed by PSYTEST Psychologische Testsysteme, Herzogenrath, which will be administered to the children. |
Between October 2021 and January 2022 |
|
Secondary |
Cognitive testing: Alertness and reactions to multiple stimuli |
Alertness and reactions to multiple stimuli will be studied by a computer-based test from the KiTAP test battery developed by PSYTEST Psychologische Testsysteme, Herzogenrath, which will be administered to the children. |
Between October 2021 and January 2022 |
|