Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01138293
Status:
COMPLETED
Last Update Posted:
2010-06-28
First Post:
2010-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], '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'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-25', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['differences between patients´ self-assessment and objective perception of physical activity and eating habits'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome.\n\nMethods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index \\[BMI\\] 31.2±5.4kg/m², body mass index standard deviation score \\[BMI-SDS\\] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children/adolescents with overweight/obesity were included admitted to our hospital'}, 'identificationModule': {'nctId': 'NCT01138293', 'briefTitle': 'Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity', 'organization': {'class': 'NETWORK', 'fullName': 'MEDIGREIF Inselklinik Heringsdorf'}, 'orgStudyIdInfo': {'id': 'MEDIGREIF 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'motion sensor integrated in a mobile phone', 'description': 'A motion sensor integrated in a mobile phone. The system analyses kind, intensity and duration of physical activity and eating habits.', 'interventionNames': ['Device: motion detection with a motion sensor']}], 'interventions': [{'name': 'motion detection with a motion sensor', 'type': 'DEVICE', 'description': 'To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.', 'armGroupLabels': ['motion sensor integrated in a mobile phone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17424', 'city': 'Heringsdorf', 'country': 'Germany', 'facility': 'MEDIGREIF Inselklinik Heringsdorf GmbH, Haus Gothensee', 'geoPoint': {'lat': 54.301, 'lon': 11.00658}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MEDIGREIF Inselklinik Heringsdorf', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Fraunhofer Institut für Graphische Datenverarbeitung (IGD), Rostock, Germany', 'class': 'UNKNOWN'}]}}}