Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT00987532
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Participatory Parental Intervention Promoting Physical Activity in Preschools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 1047}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in mean accelerometry counts over 6 days', 'timeFrame': 'baseline, end of intervention, six months after end of intervention'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'baseline, end of intervention, six months after end of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preschool', 'participatory intervention', 'cluster-randomization', 'children', 'obesity prevention'], 'conditions': ['Obesity', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '23790990', 'type': 'DERIVED', 'citation': 'De Bock F, Genser B, Raat H, Fischer JE, Renz-Polster H. A participatory physical activity intervention in preschools: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):64-74. doi: 10.1016/j.amepre.2013.01.032.'}, {'pmid': '20113522', 'type': 'DERIVED', 'citation': 'De Bock F, Fischer JE, Hoffmann K, Renz-Polster H. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial. BMC Public Health. 2010 Jan 31;10:49. doi: 10.1186/1471-2458-10-49.'}], 'seeAlsoLinks': [{'url': 'http://www.ene-mene-fit.de', 'label': 'webpage of the participatory parent-focused intervention'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.', 'detailedDescription': 'Over the last 20 years, physical activity (PA) in children has rapidly decreased in both developed and developing nations. More effective interventions to prevent inactivity in childhood thus are urgently needed. The preschool years, including the adiposity rebound period, might represent a good window of opportunity. Study literature suggests that targeting parents is crucial for lasting changes in young childrens\' behavior. However, it is not known which methods are effective for involving parents in physical activity promotion. Consistent with experience from community-based participatory research, encouraging parents to participate the intervention in terms of content and structure might lead to higher intervention effectivity and sustainability. In our study, we therefore "enriched" a child-centered physical activity intervention in preschools (twice weekly gym lessons over 6 months) with a parent-focused participatory community intervention component.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 3-6 years\n\nExclusion Criteria:\n\n* severe atopic dermatitis,\n* serious acute infectious diseases,\n* physical malformations, and\n* severe physical disabilities.'}, 'identificationModule': {'nctId': 'NCT00987532', 'briefTitle': 'A Participatory Parental Intervention Promoting Physical Activity in Preschools', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'orgStudyIdInfo': {'id': 'MIPH_KITA2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'parent intervention plus gym lessons', 'description': 'Parent-focused participatory preschool intervention in addition to twice weekly gym lessons over 6 months. The participatory intervention includes parents, teachers and children.', 'interventionNames': ['Behavioral: parent-focused intervention', 'Behavioral: twice weekly gym lessons']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gym lessons only', 'description': 'Twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months', 'interventionNames': ['Behavioral: twice weekly gym lessons']}], 'interventions': [{'name': 'parent-focused intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Ene mene fit - Eltern machen mit'], 'description': "The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.", 'armGroupLabels': ['parent intervention plus gym lessons']}, {'name': 'twice weekly gym lessons', 'type': 'BEHAVIORAL', 'otherNames': ['child-centered physical activity intervention'], 'description': 'twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months', 'armGroupLabels': ['gym lessons only', 'parent intervention plus gym lessons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Joachim E. Fischer, MD, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baden-Württemberg Stiftung gGmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Mannheim Institute of Public Health', 'investigatorFullName': 'Joachim E. Fischer, MD MSc', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}