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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077059
• Other study ID #: Schools Obesity and Overweight
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Adipositasnetzwerk Rhein-Neckar e.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Additionally, interactions between cognitive abilities and weight-status will be studied.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• Written consent from parents and or guardians

Exclusion Criteria:

• Missing consent of parents or guardians

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Adipositasnetzwerk Rhein-Neckar e.V.	Heidelberg	Baden-Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
Adipositasnetzwerk Rhein-Neckar e.V.	Gesundheitsamt Heidelberg, Oatly AB, starScience GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Overweight and obesity will be assessed based on the BMI of the children.	Between October 2021 and January 2022
Primary	zBMI	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	Body weight in kg	Body weight in kg during the study visit at schools	Between October 2021 and January 2022
Secondary	Height in cm	Height in cm during the study visit at schools	Between October 2021 and January 2022
Secondary	abdominal circumference in cm	abdominal circumference in cm during the study visit at schools	Between October 2021 and January 2022
Secondary	Upper arm circumference in cm	Upper arm circumference in cm during the study visit at schools	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	Eating habits	Eating habits will be evaluated using a 3-day food record and a questionnaire	Between October 2021 and January 2022
Secondary	Physical activity	Physical activity will be assessed using a modified PAQ-C questionnaire as well as a questionnaire for parents	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022
Secondary	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.	Between October 2021 and January 2022