Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:26 AM
Study NCT ID:
NCT01127412
Status:
COMPLETED
Last Update Posted:
2010-05-20
First Post:
2010-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-05-19', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth', 'timeFrame': 'Regularly during the first year of life, at 2.5 years of age', 'description': 'Weight, length'}, {'measure': 'Body composition', 'timeFrame': 'Regularly during the first year of life, at 2.5 years of age', 'description': 'Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)'}], 'secondaryOutcomes': [{'measure': 'Motor activity', 'timeFrame': 'At the age of 5 months, 8 months and 2.5 years of age', 'description': 'Accelerometer'}, {'measure': 'Motor development', 'timeFrame': 'At the age of 5 months, 8 months and 2.5 years of age', 'description': 'Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overweight', 'physical activity', 'infancy', 'body composition', 'motor development', 'motor activity'], 'conditions': ['Overweight', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* date of birth (December 2006-February 2008)\n* area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands)\n\nExclusion Criteria:\n\n* Children under care of child physiotherapists will be excluded from the program'}, 'identificationModule': {'nctId': 'NCT01127412', 'briefTitle': 'Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EOIP-GECKO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical activity stimulating program', 'description': 'Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months', 'interventionNames': ['Behavioral: Physical activity stimulating program']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Physical activity stimulating program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Physical activity stimulating program']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'P.J.J. Sauer MD PhD', 'oldOrganization': 'University Medical Center Groningen'}}}}