Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-12 @ 4:05 PM
Study NCT ID:
NCT03941392
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Study in Spanish Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary habits', 'timeFrame': '10 months', 'description': 'Dietary diversity and variety determinated by using a FFQ from last year of consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month'}, {'measure': 'Food', 'timeFrame': '10 months', 'description': "Food groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per food group."}, {'measure': 'Beverages', 'timeFrame': '10 months', 'description': "Beverage groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per beverage group."}, {'measure': 'Energy, macro and micronutrient composition of the diet', 'timeFrame': '10 months', 'description': 'Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls'}, {'measure': 'Active and sedentary habits', 'timeFrame': '10 months', 'description': 'Active and sedentary habits were measured with the 1-week activity recall validated in children'}, {'measure': 'Milk and dairy products consumption', 'timeFrame': '10 months', 'description': 'Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary'}, {'measure': 'Dietary quality index for children "KidMed"', 'timeFrame': '10 months', 'description': 'Evaluate the quality of the diet through this quality index for the specific age group'}], 'secondaryOutcomes': [{'measure': 'Growth and BMI', 'timeFrame': '1 year', 'description': 'Determined by reported age, weight (kg), and height (cm)'}, {'measure': 'Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake', 'timeFrame': '1 year', 'description': 'Measured by the relation between the reported energy intake and the estimated energy expenditure. The cut-off points are determined by the information reported by the population itself.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Pediatric age', 'Physical activity', 'Dairy products', 'Dairy consumption', 'Sedentary habits', 'Diet quality', 'Children'], 'conditions': ['Child, Only', 'Metabolic Diseases', 'Child Development', 'Diet Habit', 'Healthy Diet', 'Feeding Behavior', 'Health Behavior', 'Sedentary Lifestyle', 'Food Habits', 'Nutritional Status', 'Diet, Food and Nutrition']}, 'descriptionModule': {'briefSummary': 'This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern.\n\nHypothesis: The habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.', 'detailedDescription': 'A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in urban areas \\>50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Apparently healthy children between 1 to 9 years who live in an urban area with more than 50 000 inhabitants in Spain and that answer all the study recalls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns.\n* Those following dietary advice such as for prevention of non-communicable chronic diseases\n\nExclusion Criteria:\n\n* Children with any disease that cause changes in the dietary pattern and with any dietary restriction.\n* Children suffering a metabolic disease such as hyperthyroidism or hypothyroidism.\n* Children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy.\n* Children with any chronic disease that causes changes in the dietary pattern\n* Children who live in an institution (colleges, nursing homes, hospitals, host Institutions, etc )\n* Children with a transitory pathology (flu, gastroenteritis, chicken pox, etc) at the time of the fieldwork.\n* Children following a therapeutic diet due to recent surgery or any other medical prescription.\n* Children related to Lactalis or Madison MK employees.\n* Children whose parents or caregivers did not provide a signed consent form for their participation or not completed any study phase.'}, 'identificationModule': {'nctId': 'NCT03941392', 'acronym': 'EsNuPI', 'briefTitle': 'Nutritional Study in Spanish Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Iberoamericana de Nutricion'}, 'officialTitle': 'Nutritional Study in Spanish Pediatric Population (EsNuPI)', 'orgStudyIdInfo': {'id': 'FF01/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy children between 1 and 9 years old', 'description': 'A sample of 1500 apparently healthy children between 1 to 9 years old from urban areas from different regions of Spain.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Fundación Iberoamericana de Nutrición', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Iberoamericana de Nutricion', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad de Granada', 'class': 'OTHER'}, {'name': 'Fundación Española de la Nutrición', 'class': 'OTHER'}, {'name': 'CEU San Pablo University', 'class': 'OTHER'}, {'name': 'Lactalis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}