- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077059
Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany
Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany - a Cross-Sectional Study / Adipositasprävalenz Bei Grundschulkindern in Der Rhein-Neckar Region - Eine Querschnittsstudie
Study Overview
Status
Detailed Description
The prevalence of obesity and overweight is increasing among both adults and children. School and kindergarten closings during the COVID-19 epidemic may have had an additional negative impact on the weight development of the affected children. This study aims to examine the post-lockdown prevalence of overweight and obesity in school children in the second grade in the Rhein-Neckar Region in Germany and look at possible lockdown effects. Additionally, interactions between cognitive abilities and weight-status will be studied.
Anthropometric measurements, interviews as well as cognitive testing will be performed in schools in the summer of 2021 in children in the first grade (class 2020/2021). Parents will be asked to provide measurements from U-childhood-examinations and complete a 3-day food record. The local health authority (Gesundheitsamt) will assist in making a representative selection of schools from different socioeconomic areas and provide data from the pre-school examinations. Collected data will be analyzed and compared to national and international surveys, evaluating the trends of the children's height and weight development. Weight status will be assessed by calculating z-BMI standardized for age and compared with national and international growth charts using both national and WHO classification. Potential interrelation between weight-status, weight development with cognitive performance will be explored.
The study will be able to deliver valuable insights in regards to the health of school children in the Rhein-Neckar Region as well as evaluate the effect of COVID-19 related lockdowns on their health.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69115
- Adipositasnetzwerk Rhein-Neckar e.V.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written consent from parents and or guardians
Exclusion Criteria:
- Missing consent of parents or guardians
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: Between October 2021 and January 2022
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Overweight and obesity will be assessed based on the BMI of the children.
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Between October 2021 and January 2022
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zBMI
Time Frame: Through study completion, an average of 4 months
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zBMI will be calculated using German and WHO growth curves / distributions for evaluating child weight status.
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Through study completion, an average of 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight in kg
Time Frame: Between October 2021 and January 2022
|
Body weight in kg during the study visit at schools
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Between October 2021 and January 2022
|
|
Height in cm
Time Frame: Between October 2021 and January 2022
|
Height in cm during the study visit at schools
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Between October 2021 and January 2022
|
|
abdominal circumference in cm
Time Frame: Between October 2021 and January 2022
|
abdominal circumference in cm during the study visit at schools
|
Between October 2021 and January 2022
|
|
Upper arm circumference in cm
Time Frame: Between October 2021 and January 2022
|
Upper arm circumference in cm during the study visit at schools
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Between October 2021 and January 2022
|
|
Body weight at the time of the U8 physical examination
Time Frame: Between October 2021 and January 2022
|
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.
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Between October 2021 and January 2022
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Height at the time of the U8 physical examination
Time Frame: Between October 2021 and January 2022
|
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
|
|
BMI at the time of the U8 physical examination
Time Frame: Between October 2021 and January 2022
|
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
|
|
Body weight at the time of the U9 physical examination
Time Frame: Between October 2021 and January 2022
|
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
|
|
Height at the time of the U9 physical examination
Time Frame: Between October 2021 and January 2022
|
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
|
|
BMI at the time of the U9 physical examination
Time Frame: Between October 2021 and January 2022
|
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
|
|
Body weight S1 examination data
Time Frame: Between October 2021 and January 2022
|
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
|
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Height at the time of the S1 examination data
Time Frame: Between October 2021 and January 2022
|
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
|
|
BMI at the time of the S1 examination data
Time Frame: Between October 2021 and January 2022
|
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
|
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Eating habits
Time Frame: Between October 2021 and January 2022
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Eating habits will be evaluated using a 3-day food record and a questionnaire
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Between October 2021 and January 2022
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Physical activity
Time Frame: Between October 2021 and January 2022
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Physical activity will be assessed using a modified PAQ-C questionnaire as well as a questionnaire for parents
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Between October 2021 and January 2022
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Cognitive testing: Distractibility
Time Frame: Between October 2021 and January 2022
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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.
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Between October 2021 and January 2022
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Cognitive testing: Cognitive flexibility
Time Frame: Between October 2021 and January 2022
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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.
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Between October 2021 and January 2022
|
|
Cognitive testing: Alertness and reactions to multiple stimuli
Time Frame: Between October 2021 and January 2022
|
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.
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Between October 2021 and January 2022
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Collaborators and Investigators
Investigators
- Principal Investigator: Erhard Siegel, MD, Adipositasnetzwerk Rhein-Neckar
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Schools Obesity and Overweight
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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