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

August 15, 2022 updated by: Adipositasnetzwerk Rhein-Neckar e.V.

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.

Study Overview

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

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children in the second grade

Description

Inclusion Criteria:

  • Written consent from parents and or guardians

Exclusion Criteria:

  • Missing consent of parents or guardians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Overweight and obesity will be assessed based on the BMI of the children.
Between October 2021 and January 2022
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.
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
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
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
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.
Between October 2021 and January 2022
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
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
Eating habits
Time Frame: Between October 2021 and January 2022
Eating habits will be evaluated using a 3-day food record and a questionnaire
Between October 2021 and January 2022
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
Between October 2021 and January 2022
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.
Between October 2021 and January 2022
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.
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.
Between October 2021 and January 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erhard Siegel, MD, Adipositasnetzwerk Rhein-Neckar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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