NCT05077059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

September 21, 2021

Last Update Submit

August 15, 2022

Conditions

Keywords

overweightobesitychildrencognitive functioncognitive function and weight status

Outcome Measures

Primary Outcomes (2)

  • BMI

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

    Between October 2021 and January 2022

  • 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 Outcomes (18)

  • Body weight in kg

    Between October 2021 and January 2022

  • Height in cm

    Between October 2021 and January 2022

  • abdominal circumference in cm

    Between October 2021 and January 2022

  • Upper arm circumference in cm

    Between October 2021 and January 2022

  • Body weight at the time of the U8 physical examination

    Between October 2021 and January 2022

  • +13 more secondary outcomes

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children in the second grade

You may qualify if:

  • Written consent from parents and or guardians

You may not qualify if:

  • Missing consent of parents or guardians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adipositasnetzwerk Rhein-Neckar e.V.

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Related Publications (2)

  • Samigullin A, Gahlert J, Gross G, Morcos M, Schwertz R, Oste R, Siegel E, Humpert P. A central role of nutrition in cognitive function among primary school children: a cross-sectional analysis. BMC Nutr. 2025 Feb 10;11(1):35. doi: 10.1186/s40795-025-01016-2.

  • Samigullin A, Gross G, Gahlert J, Buchenberger S, Morcos M, Schwertz R, Oste R, Siegel E, Humpert P. Impact of Covid-19 lockdowns on the anthropometric development in primary school children in the Rhein-Neckar Region, Germany. BMC Nutr. 2024 May 29;10(1):78. doi: 10.1186/s40795-024-00886-2.

MeSH Terms

Conditions

Pediatric ObesityOverweightObesityThinness

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erhard Siegel, MD

    Adipositasnetzwerk Rhein-Neckar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 13, 2021

Study Start

October 1, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations