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Completed

NCT Number: NCT05077059

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

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.

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Key information

Conditions

Overweight, Childhood Body Weight Child Development Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Childhood Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Thinness Underweight

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adipositasnetzwerk Rhein-Neckar e.V.

Heidelberg, Baden-Wurttemberg, 69115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written consent from parents and or guardians

Exclusion criteria

  • Missing consent of parents or guardians

Treatment and study plan

Primary outcomes

  1. BMI

    Time frame: Between October 2021 and January 2022

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

  2. zBMI

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

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

Secondary outcomes

  1. Body weight in kg

    Time frame: Between October 2021 and January 2022

    Body weight in kg during the study visit at schools

  2. Height in cm

    Time frame: Between October 2021 and January 2022

    Height in cm during the study visit at schools

  3. abdominal circumference in cm

    Time frame: Between October 2021 and January 2022

    abdominal circumference in cm during the study visit at schools

  4. Upper arm circumference in cm

    Time frame: Between October 2021 and January 2022

    Upper arm circumference in cm during the study visit at schools

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Eating habits

    Time frame: Between October 2021 and January 2022

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

  15. Physical activity

    Time frame: Between October 2021 and January 2022

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

  16. Cognitive testing: Distractibility

    Time frame: Between October 2021 and January 2022

    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.

  17. Cognitive testing: Cognitive flexibility

    Time frame: Between October 2021 and January 2022

    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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Adipositasnetzwerk Rhein-Neckar e.V.

Other

Collaborators

  • Gesundheitsamt Heidelberg
  • Oatly AB
  • starScience GmbH

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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