Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 5:23 AM
Study NCT ID:
NCT00349232
Status:
UNKNOWN
Last Update Posted:
2006-07-10
First Post:
2006-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention in Obese Children Attending Special Primary Education.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2007-07'}, 'lastUpdateSubmitDate': '2006-07-06', 'studyFirstSubmitDate': '2006-07-04', 'studyFirstSubmitQcDate': '2006-07-04', 'lastUpdatePostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bodyweight after 3 and 6 months'}, {'measure': 'Bodycomposition after 3 and 6 months'}, {'measure': 'Bodyfat distribution after 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Eating behavior after 3 and 6 months'}, {'measure': 'Physical activity after 3 and 6 months'}, {'measure': 'Quality of life after 3 and 6 months'}]}, 'conditionsModule': {'keywords': ['childhood obesity', 'lifestyle intervention', 'school health program', 'special primary education'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '15096099', 'type': 'BACKGROUND', 'citation': 'Lobstein T, Baur L, Uauy R; IASO International Obesity TaskForce. Obesity in children and young people: a crisis in public health. Obes Rev. 2004 May;5 Suppl 1:4-104. doi: 10.1111/j.1467-789X.2004.00133.x. No abstract available.'}, {'pmid': '11319638', 'type': 'BACKGROUND', 'citation': 'Hulens M, Beunen G, Claessens AL, Lefevre J, Thomis M, Philippaerts R, Borms J, Vrijens J, Lysens R, Vansant G. Trends in BMI among Belgian children, adolescents and adults from 1969 to 1996. Int J Obes Relat Metab Disord. 2001 Mar;25(3):395-9. doi: 10.1038/sj.ijo.0801513.'}, {'pmid': '10340798', 'type': 'BACKGROUND', 'citation': 'Must A, Strauss RS. Risks and consequences of childhood and adolescent obesity. Int J Obes Relat Metab Disord. 1999 Mar;23 Suppl 2:S2-11. doi: 10.1038/sj.ijo.0800852.'}, {'pmid': '11157310', 'type': 'BACKGROUND', 'citation': 'Goran MI. Metabolic precursors and effects of obesity in children: a decade of progress, 1990-1999. Am J Clin Nutr. 2001 Feb;73(2):158-71. doi: 10.1093/ajcn/73.2.158.'}, {'pmid': '9130034', 'type': 'BACKGROUND', 'citation': 'Van Gaal LF, Wauters MA, De Leeuw IH. The beneficial effects of modest weight loss on cardiovascular risk factors. Int J Obes Relat Metab Disord. 1997 Mar;21 Suppl 1:S5-9.'}, {'pmid': '10201726', 'type': 'BACKGROUND', 'citation': 'Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixit S, Fox MK, Laird N. Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health. Arch Pediatr Adolesc Med. 1999 Apr;153(4):409-18. doi: 10.1001/archpedi.153.4.409.'}, {'pmid': '15960869', 'type': 'BACKGROUND', 'citation': 'Muller MJ, Danielzik S, Pust S. School- and family-based interventions to prevent overweight in children. Proc Nutr Soc. 2005 May;64(2):249-54. doi: 10.1079/pns2005424.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the prevalence of overweight and obesity in children attending special primary education and to evaluate the effects of a multidisciplinary school-based lifestyle intervention.', 'detailedDescription': "Lifestyle changes related to high-fat diets and low levels of physical activity have resulted in a rising prevalence of overweight and obesity in children and adolescents. Ten per cent of the world's school-aged children are estimated to have excess body fat. Overweight and obesity during childhood and adolescence tend to continue into adulthood, increasing the likelihood of a range of impaired health conditions including cardiovascular diseases, diabetes and some cancers. School-based interventions have been proposed to prevent or treat obesity and have been described as a promising approach to reducing obesity among youth. First the extent and the characteristics of the problem have to be assessed for different types of education.\n\nComparison(s): the prevalence of overweight and obesity in special primary education will be compared to the prevalence in regular primary education. In special primary education, obese and overweight children will be randomised into a experimentel group (6 months of lifestyle intervention including diet and physical activity) and a control group (6 months normal treatment, if any, e.g. exercises for motor skills)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children attending special and regular primary education\n\nExclusion Criteria:\n\n* endocrine conditions affecting bodyweight (e.g. thyroid disease, diabetes)\n* mental or physical disabilities that make it impossible to participate in sports activities'}, 'identificationModule': {'nctId': 'NCT00349232', 'briefTitle': 'Lifestyle Intervention in Obese Children Attending Special Primary Education.', 'organization': {'class': 'OTHER', 'fullName': 'University College of Antwerp'}, 'officialTitle': 'Prevalence of Overweight and Obesity in Children Attending Special Primary Education and the Effect of a Lifestyle Intervention.', 'orgStudyIdInfo': {'id': 'HA-KINE-2006-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lifestyle intervention (diet and physical activity)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2970', 'city': 'Antwerp', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'MPI Zonnebos', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'centralContacts': [{'name': 'Dirk Vissers', 'role': 'CONTACT', 'email': 'd.vissers@ha.be', 'phone': '00 32 3 6418265'}], 'overallOfficials': [{'name': 'Steven Truijen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University College of Antwerp'}, {'name': 'Luc Van Gaal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}, {'name': 'Dirk Vissers', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College of Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College of Antwerp', 'class': 'OTHER'}}}}