Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05966051
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate prevalence of childhood overweight and/or obesity', 'timeFrame': 'Baseline', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Investigation on adherence to Mediterranian diet', 'timeFrame': 'Baseline', 'description': 'Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.'}, {'measure': 'Assessment of the consumption of ultra-processed food by children', 'timeFrame': 'Baseline', 'description': 'NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)'}, {'measure': 'Investigation of family lifestyles', 'timeFrame': 'Baseline', 'description': "Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five."}], 'secondaryOutcomes': [{'measure': 'Feasibility of multidimensional school-based educational interventions', 'timeFrame': '6 months', 'description': 'Perception of usefulness of the interventions: appreciation questionnaires to investigate the satisfaction of the implemented activities; organization of the interventions and usefulness of the educational interventions'}, {'measure': 'Investigation of changes in adherence to Mediterranian diet', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.'}, {'measure': 'Assessment of changes of the consumption of ultra-processed food by children', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)'}, {'measure': 'Investigation of changes of family lifestyles', 'timeFrame': 'Baseline, 6 and 12 months', 'description': "Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood Obesity Prevention', 'Childhood Obesity determinants', 'Educational Interventions', 'Primary schools'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '39475855', 'type': 'BACKGROUND', 'citation': 'Basilico S, Conti MV, Ardoino I, Breda C, Loperfido F, Klaic E, Spialtini L, Foresta A, Orsini F, Ojeda Fernandez ML, Conca Bonizzoni S, Modena E, Tootoonchi Hamedani Y, Villa F, Cena H, Baviera M, Franchi C. Multidimensional School-Based and Family-Involved Interventions to Promote a Healthy and Sustainable Lifestyle (LIVELY) for Childhood Obesity Prevention: Study Protocol. JMIR Res Protoc. 2024 Oct 30;13:e57509. doi: 10.2196/57509.'}]}, 'descriptionModule': {'briefSummary': 'Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century.\n\nThe overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior.\n\nTo counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term.\n\nMoreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective.\n\nThe LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.', 'detailedDescription': 'LIVELY is a study with a one group pre-test - post-test design (without control). The study will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy Region, Northern Italy). The study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate.\n\nThe educational interventions will consist in:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will involve children 6-11 years old, attending the primary school Istituto Luigi Cadorna in Milano (Lombardy Region -Northern Italy) and their families.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children 6-11 years\n* children whose parents will provide written consent to participate.\n\nExclusion Criteria:\n\n* Children who do not have inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05966051', 'acronym': 'LIVELY', 'briefTitle': 'MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': 'MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study', 'orgStudyIdInfo': {'id': 'IRFMN-8979'}, 'secondaryIdInfos': [{'id': 'F13C22001210007', 'type': 'OTHER', 'domain': 'University of Pavia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children attending primary school', 'description': 'In this study will be included children 6-11 years and their families, whose parents will provide written consent to participate,', 'interventionNames': ['Behavioral: Educational interventions']}], 'interventions': [{'name': 'Educational interventions', 'type': 'BEHAVIORAL', 'description': 'The educational interventions will consist in:', 'armGroupLabels': ['Children attending primary school']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Istituto Comprensivo Luigi Cadorna', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Carlotta Franchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mario Negri Institute for Pharmacological Research'}, {'name': 'Marta Baviera, PharmDr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mario Negri Institute for Pharmacological Research'}, {'name': 'Maria Vittoria Conti, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}