Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00916318
Status:
UNKNOWN
Last Update Posted:
2009-06-09
First Post:
2009-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Childhood Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-08', 'studyFirstSubmitDate': '2009-06-05', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure: BMI', 'timeFrame': '6 months, 1 year, 2 year, 5 year'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention', 'timeFrame': '6 months, 1 year, 2 year, 5 year'}]}, 'conditionsModule': {'conditions': ['Childhood Obesity', 'Childhood Overweight']}, 'referencesModule': {'references': [{'pmid': '23072247', 'type': 'DERIVED', 'citation': 'Onnerfalt J, Erlandsson LK, Orban K, Broberg M, Helgason C, Thorngren-Jerneck K. A family-based intervention targeting parents of preschool children with overweight and obesity: conceptual framework and study design of LOOPS- Lund overweight and obesity preschool study. BMC Public Health. 2012 Oct 17;12:879. doi: 10.1186/1471-2458-12-879.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program.', 'detailedDescription': 'The aim is to investigate the possibility of preventing the development of obesity in early childhood. To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. To compare different methods of treatment by randomizing the families into groups with various treatment during one year; (A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group. To analyse the aetiology and prognosis of overweight and obesity in early childhood, by measuring the following variables: heredity, genetics, perinatal, physiological, metabolism, bio-chemical, clinical, psychological, socio-economic. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program. To calculate the prevalence of overweight and obesity among pre-school children in the county of Middle Skåne during a 20 year period. To analyse parents actual utilization of the Sundabarn.se and in association with primary and secondary outcome. To analyse the cost-effectiveness of the intervention programs.\n\nThe primary outcome variable, BMI of the children, is measured at inclusion, after six months, at exclusion and one year after end of program.\n\nFollowing variables are investigated and related to BMI of children before and after intervention: Heredity: BMI of parents, history . Socio-economic background: education, salary, language, occupation of parents. Perinatal data: Mothers BMI, parity, smoking, ponderal index of infant, gender, breast-feeding. Psychological variables: grading of parents experienced stress and control and psychological health of the child, before end after intervention. Are there a correlation between change in these factors and change in BMI of the child after the intervention? Physiological variables: Sleep duration and activity patterns in the children and compare them to BMI Analysing sleep duration and activity with an accelerometer. Analysing dietary of children: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention: metabolism of insulin (glc, insulin, C-peptide, pro-insulin, HBA1C) lipids (TG, HDL, LDL, cholesterole), adipokins and cytokins (leptin, adinopektin, resistin, haptoglobulin, IL-6, TNFalfa),ghrelin before and after a meal, thyroid (TSH, T3). Analysing the bacteria of the gastro-intestinal tract by sample from stools.\n\nUtilization of SundaBarn.se: automatic, electronic measurement by single user identity of number of sessions, pages visited, inputs made and downloads.\n\nIntervention health-care resource use: Protocol driven visits to physician, nurse, occupational therapist, psychologist, dietitian.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-6 y\n* BMI due to Cole criteria as overweight or obesity\n\nExclusion Criteria:\n\n* Medical disorders\n* Endocrine disorders'}, 'identificationModule': {'nctId': 'NCT00916318', 'briefTitle': 'Childhood Overweight', 'organization': {'class': 'OTHER', 'fullName': 'Vardalinstitutet The Swedish Institute for Health Sciences'}, 'officialTitle': 'Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health', 'orgStudyIdInfo': {'id': 'Obesity-Chrildren Vardal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: experimental', 'description': '(A) internet based information and communication tool "Sundabarn.se"(', 'interventionNames': ['Behavioral: Obesity-Children']}, {'type': 'EXPERIMENTAL', 'label': '(B): experimental', 'description': '(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A', 'interventionNames': ['Behavioral: Obesity-Children']}, {'type': 'EXPERIMENTAL', 'label': '(c): experimental', 'description': '(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A', 'interventionNames': ['Behavioral: Obesity-Children']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(D): control group', 'interventionNames': ['Behavioral: Obesity-Children']}], 'interventions': [{'name': 'Obesity-Children', 'type': 'BEHAVIORAL', 'description': '(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.', 'armGroupLabels': ['(B): experimental', '(D): control group', '(c): experimental', 'A: experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Kristina Thorngren-Jerneck, phd', 'role': 'CONTACT', 'email': 'Kristina.Thorngren-Jerneck@med.lu.se'}], 'facility': "Lund University Childrens' hospital", 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Kristian Bolin, phd', 'role': 'CONTACT', 'email': 'Kristian.Bolin@nek.lu.se', 'phone': '+46 46 2228655'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vardalinstitutet The Swedish Institute for Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Principal investigator: Kristina Thorngren-Jerneck', 'oldOrganization': 'Lund university Hospital'}}}}