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Overweight, ChildhoodNCT05077059

Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany

An observational study of Overweight, Childhood and Obesity, Childhood, run by Adipositasnetzwerk Rhein-Neckar e.V. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will determine the weight status in primary school children in the Rhein-Neckar Region in Germany and will analyse the development of height and weight in these children during the time of COVID-19 related restrictions by asking parents to provide data from childhood examinations. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
How many people
250 participants
Where
1 siteGermany
Study dates
1 Oct 2021to 30 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children in the second grade

Who may be able to join

  • Written consent from parents and or guardians

Who cannot join

  • Missing consent of parents or guardians

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Adipositasnetzwerk Rhein-Neckar e.V.

    Heidelberg, Baden-Wurttemberg, 69115

Other trials in Germany

About this study

Official title: 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

The study will determine the weight status in primary school children in the Rhein-Neckar Region in Germany and will analyse the development of height and weight in these children during the time of COVID-19 related restrictions by asking parents to provide data from childhood examinations. Additionally, interactions between cognitive abilities and weight-status will be studied.

Read the 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.

Keywords
overweight, obesity, children, cognitive function, cognitive function and weight status
Medical subject headings
Pediatric Obesity, Overweight, Obesity, Thinness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Overweight and obesity will be assessed based on the BMI of the children.

    Measured: Between October 2021 and January 2022

  2. zBMI

    zBMI will be calculated using German and WHO growth curves / distributions for evaluating child weight status.

    Measured: Through study completion, an average of 4 months

Secondary outcomes (18)

  1. Body weight in kg

    Body weight in kg during the study visit at schools

    Measured: Between October 2021 and January 2022

  2. Height in cm

    Height in cm during the study visit at schools

    Measured: Between October 2021 and January 2022

  3. abdominal circumference in cm

    abdominal circumference in cm during the study visit at schools

    Measured: Between October 2021 and January 2022

  4. Upper arm circumference in cm

    Upper arm circumference in cm during the study visit at schools

    Measured: Between October 2021 and January 2022

  5. 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.

    Measured: Between October 2021 and January 2022

  6. 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.

    Measured: Between October 2021 and January 2022

  7. 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.

    Measured: Between October 2021 and January 2022

  8. 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.

    Measured: Between October 2021 and January 2022

  9. 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.

    Measured: Between October 2021 and January 2022

  10. 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.

    Measured: Between October 2021 and January 2022

  11. 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.

    Measured: Between October 2021 and January 2022

  12. 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.

    Measured: Between October 2021 and January 2022

  13. 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.

    Measured: Between October 2021 and January 2022

  14. Eating habits

    Eating habits will be evaluated using a 3-day food record and a questionnaire

    Measured: Between October 2021 and January 2022

  15. Physical activity

    Physical activity will be assessed using a modified PAQ-C questionnaire as well as a questionnaire for parents

    Measured: Between October 2021 and January 2022

  16. 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.

    Measured: Between October 2021 and January 2022

  17. 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.

    Measured: Between October 2021 and January 2022

  18. 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.

    Measured: Between October 2021 and January 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start1 Oct 2021
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077059
Sponsor's protocol ID
Schools Obesity and Overweight
Status last verified
Aug 2022
First submitted
21 Sep 2021
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Samigullin A, Gahlert J, Gross G, Morcos M, Schwertz R, Oste R, Siegel E, Humpert P. A central role of nutrition in cognitive function among primary school children: a cross-sectional analysis. BMC Nutr. 2025 Feb 10;11(1):35. doi: 10.1186/s40795-025-01016-2.

    PubMed 39930520

  • Samigullin A, Gross G, Gahlert J, Buchenberger S, Morcos M, Schwertz R, Oste R, Siegel E, Humpert P. Impact of Covid-19 lockdowns on the anthropometric development in primary school children in the Rhein-Neckar Region, Germany. BMC Nutr. 2024 May 29;10(1):78. doi: 10.1186/s40795-024-00886-2.

    PubMed 38811974

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight, Childhood and Obesity, Childhood, run by Adipositasnetzwerk Rhein-Neckar e.V. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: Between October 2021 and January 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077059, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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