Clinical trial NCT05077059: Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight, Childhood
Obesity, Childhood
Child Development
Overweight and Obesity
Underweight
Keywords: overweight
obesity
children
cognitive function
cognitive function and weight status
Lead sponsor: Adipositasnetzwerk Rhein-Neckar e.V.
Sponsor class: OTHER
Collaborators: name: Gesundheitsamt Heidelberg
name: starScience GmbH
name: Oatly AB
First posted: 2021-10-13
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in the second grade

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Written consent from parents and or guardians

Exclusion Criteria:

* Missing consent of parents or guardians

Primary outcomes:
measure: BMI
timeFrame: Between October 2021 and January 2022
measure: zBMI
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Body weight in kg
timeFrame: Between October 2021 and January 2022
measure: Height in cm
timeFrame: Between October 2021 and January 2022
measure: abdominal circumference in cm
timeFrame: Between October 2021 and January 2022
measure: Upper arm circumference in cm
timeFrame: Between October 2021 and January 2022
measure: Body weight at the time of the U8 physical examination
timeFrame: Between October 2021 and January 2022
measure: Height at the time of the U8 physical examination
timeFrame: Between October 2021 and January 2022
measure: BMI at the time of the U8 physical examination
timeFrame: Between October 2021 and January 2022
measure: Body weight at the time of the U9 physical examination
timeFrame: Between October 2021 and January 2022
measure: Height at the time of the U9 physical examination
timeFrame: Between October 2021 and January 2022
measure: BMI at the time of the U9 physical examination
timeFrame: Between October 2021 and January 2022
measure: Body weight S1 examination data
timeFrame: Between October 2021 and January 2022
measure: Height at the time of the S1 examination data
timeFrame: Between October 2021 and January 2022
measure: BMI at the time of the S1 examination data
timeFrame: Between October 2021 and January 2022
measure: Eating habits
timeFrame: Between October 2021 and January 2022
measure: Physical activity
timeFrame: Between October 2021 and January 2022
measure: Cognitive testing: Distractibility
timeFrame: Between October 2021 and January 2022
measure: Cognitive testing: Cognitive flexibility
timeFrame: Between October 2021 and January 2022
measure: Cognitive testing: Alertness and reactions to multiple stimuli
timeFrame: Between October 2021 and January 2022
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Adipositasnetzwerk Rhein-Neckar e.V.
state: Baden-Württemberg
Study officials:
affiliation: Adipositasnetzwerk Rhein-Neckar
name: Erhard Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References: