Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-31 @ 6:11 AM
Study NCT ID:
NCT04286932
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Children's Food Survey II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food and nutrient intake of Irish children (5-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Participating families were asked to record detailed information on the amount and type of all foods, drinks and nutritional supplements consumed by the child over four consecutive days (including one weekend day) in a food diary. Participants were provided with digital food scales and asked to weigh as many foods as possible, including leftovers. Where foods were not weighed, researchers used age-appropriate photographic food atlases, standard portion sizes and household measures at subsequent visits to help with quantifying the amount of food consumed. Participants were encouraged to keep food packaging to provide further detail on the foods consumed. Nutrient intakes were estimated from food intakes using tables of food composition.'}, {'measure': 'Anthropometry measurements of Irish children (5-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Physical measurements (height, weight, % body fat, and waist and hip circumference) of the children were made.'}, {'measure': 'Health and Lifestyle Characteristics of Irish children (5-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Participants and parents/guardians completed a questionnaire on general health and lifestyle.'}, {'measure': 'Food Choice Behaviour of Irish children (5-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Participants and parents/guardians completed questionnaires on determinants of food choice and eating behaviours for the child.'}, {'measure': 'Physical Activity Measurements of Irish children (5-8y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Physical activity was estimated using the validated Child Physical Activity Questionnaire (C-PAQ) in 5-8 year olds.'}, {'measure': 'Physical Activity Measurements of Irish children (9-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'Physical activity was estimated using the the Youth Physical Activity Questionnaire (Y-PAQ) in 9-12 year olds.'}, {'measure': 'Urine sample collection and analysis of Irish children (5-12y)', 'timeFrame': 'Jan 2017-Dec 2019', 'description': 'A single first-void morning urine sample was also collected from children during the recording period to estimate sodium and potassium intake.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Habits', 'Life Style', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to establish for the Republic of Ireland (ROI) a nationally representative database of food consumption in children aged 5-12 years to update 2003-04 data for this group and to complement more recent data on preschool children and adults. The survey will be comparable with existing survey data in ROI and with surveys in UK (GB \\& NI). The ROI database will be designed to address both nutrition and food safety issues of relevance to the development and implementation of public health policy, food safety risk assessment and to the needs of the food industry. In addition to detailed data on food consumption, data will be also be collected on body weight, lifestyle, including physical activity, determinants of food choice, urine, and composition of foods and food recipes. Food composition databases will be updated and restructured to facilitate future analyses of food ingredients, packaging materials, residues, contaminants, allergens, bioactives and microorganisms. Urine samples will be stored to facilitate future analyses nutrition and metabolic indicators, markers of food intake and for estimating exposure to food chemicals. Data will be analysed to estimate intakes of foods and nutrients and compliance with dietary recommendations, to establish the prevalence of overweight and obesity, to investigate physical activity patterns and compliance with guidelines, to identify psychological, social and attitudinal determinants of food choice and eating behaviour. Salt intake will be estimated from urine excretion. Findings will be disseminated to relevant stakeholders. The project will be carried out by a multi-disciplinary research team with strong linkages to related on-going research in food and health sciences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary school children living in Ireland; 5-12y; representative of age, gender, social class, location of residence', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending primary school\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04286932', 'acronym': 'NCFS II', 'briefTitle': "National Children's Food Survey II", 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': "National Children's Food Consumption Survey II", 'orgStudyIdInfo': {'id': '15 F 673'}}, 'armsInterventionsModule': {'armGroups': [{'label': '5-12y'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cork', 'country': 'Ireland', 'facility': 'University College Cork', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}, {'name': 'Dublin Institute of Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Janette Walton', 'investigatorAffiliation': 'University College Cork'}}}}