Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 9:55 AM
Study NCT ID:
NCT05077059
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D013851', 'term': 'Thinness'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Overweight and obesity will be assessed based on the BMI of the children.'}, {'measure': 'zBMI', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'zBMI will be calculated using German and WHO growth curves / distributions for evaluating child weight status.'}], 'secondaryOutcomes': [{'measure': 'Body weight in kg', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Body weight in kg during the study visit at schools'}, {'measure': 'Height in cm', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Height in cm during the study visit at schools'}, {'measure': 'abdominal circumference in cm', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'abdominal circumference in cm during the study visit at schools'}, {'measure': 'Upper arm circumference in cm', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Upper arm circumference in cm during the study visit at schools'}, {'measure': 'Body weight at the time of the U8 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Height at the time of the U8 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'BMI at the time of the U8 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Body weight at the time of the U9 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Height at the time of the U9 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'BMI at the time of the U9 physical examination', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Body weight S1 examination data', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Height at the time of the S1 examination data', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'BMI at the time of the S1 examination data', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Eating habits', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Eating habits will be evaluated using a 3-day food record and a questionnaire'}, {'measure': 'Physical activity', 'timeFrame': 'Between October 2021 and January 2022', 'description': 'Physical activity will be assessed using a modified PAQ-C questionnaire as well as a questionnaire for parents'}, {'measure': 'Cognitive testing: Distractibility', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Cognitive testing: Cognitive flexibility', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}, {'measure': 'Cognitive testing: Alertness and reactions to multiple stimuli', 'timeFrame': 'Between October 2021 and January 2022', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'obesity', 'children', 'cognitive function', 'cognitive function and weight status'], 'conditions': ['Overweight, Childhood', 'Obesity, Childhood', 'Child Development', 'Overweight and Obesity', 'Underweight']}, 'referencesModule': {'references': [{'pmid': '39930520', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38811974', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAnthropometric 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children in the second grade', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written consent from parents and or guardians\n\nExclusion Criteria:\n\n* Missing consent of parents or guardians'}, 'identificationModule': {'nctId': 'NCT05077059', 'briefTitle': 'Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany', 'organization': {'class': 'OTHER', 'fullName': 'Adipositasnetzwerk Rhein-Neckar e.V.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Schools Obesity and Overweight'}}, 'contactsLocationsModule': {'locations': [{'zip': '69115', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Adipositasnetzwerk Rhein-Neckar e.V.', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Erhard Siegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adipositasnetzwerk Rhein-Neckar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adipositasnetzwerk Rhein-Neckar e.V.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gesundheitsamt Heidelberg', 'class': 'UNKNOWN'}, {'name': 'starScience GmbH', 'class': 'UNKNOWN'}, {'name': 'Oatly AB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}