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CompletedNCT05077059Updated Aug 16, 2022

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

An observational study in Overweight, Childhood, Obesity, Childhood and Child Development, sponsored by Adipositasnetzwerk Rhein-Neckar e.V.. Completed at 1 site in Germany. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Adipositasnetzwerk Rhein-Neckar e.V. · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
250
Ages
6 Years to 8 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Overweight, Childhood
  • Obesity, Childhood
  • Child Development
  • Overweight and Obesity
  • Underweight

Keywords

  • overweight
  • obesity
  • children
  • cognitive function
  • cognitive function and weight status
03

In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 250 is above the median of 180 across 235 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

This is the only study on the registry with Adipositasnetzwerk Rhein-Neckar e.V. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children in the second grade

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written consent from parents and or guardians

Exclusion criteria

Exclusion Criteria:

  • Missing consent of parents or guardians
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
250 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. BMI

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

    Time frame: Between October 2021 and January 2022

  2. zBMI

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

    Time frame: Through study completion, an average of 4 months

Secondary outcomes

  1. Body weight in kg

    Body weight in kg during the study visit at schools

    Time frame: Between October 2021 and January 2022

  2. Height in cm

    Height in cm during the study visit at schools

    Time frame: Between October 2021 and January 2022

  3. abdominal circumference in cm

    abdominal circumference in cm during the study visit at schools

    Time frame: Between October 2021 and January 2022

  4. Upper arm circumference in cm

    Upper arm circumference in cm during the study visit at schools

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Between October 2021 and January 2022

  14. Eating habits

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Between October 2021 and January 2022

07

Study locations

1 site
  • Adipositasnetzwerk Rhein-Neckar e.V.
    Heidelberg, Baden-Württemberg 69115, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05077059
Lead sponsor
Adipositasnetzwerk Rhein-Neckar e.V.
Collaborators
Gesundheitsamt Heidelberg, starScience GmbH, Oatly AB
Responsible party
Sponsor
First posted
Oct 13, 2021
Start date
Oct 1, 2021
Primary completion
Jul 30, 2022
Completion
Jul 30, 2022
Last update
Aug 16, 2022

Study contacts

Erhard Siegel, MD
principal investigator · Adipositasnetzwerk Rhein-Neckar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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