Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT05249166
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feeding for Accesible, Affordable and Healthy Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Pattern (questionnaire)', 'timeFrame': 'Baseline', 'description': 'Evaluate differences in dietary pattern between groups'}, {'measure': 'Dietary pattern (questionnaire)', 'timeFrame': '8 week', 'description': 'Evaluate differences in dietary pattern between groups'}, {'measure': 'Dietary pattern (questionnaire)', 'timeFrame': 'Baseline vs 8 week', 'description': 'Evaluated changes in dietary pattern'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Children']}, 'descriptionModule': {'briefSummary': 'The main objective of this study was to evaluate the effectiveness of implementing a healthy eating vs traditional recommendations on the Medkid index of children in primary school. To do so, different companies involved in ALINFA project developed with the assessment of UNAV, CNTA and UPNA, a healthy bi-weekly menu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adequate cultural level and comprehension of the clinical study from the legal tutors.\n* To agree in taking part of the study.\n\nExclusion Criteria:\n\n* Children presenting clinically relevant gastrointestinal malfunctions or structural anomalies, such as ulcers, chronic inflammatory diseases, etc. Even if they do not follow any pharmacological treatment at the moment of inclusion.\n* Children with uncontrolled endocrine disorders.\n* Children with any type of tumor/cancer within the last 5 years, or in current treatment.\n* Children with any alimentary allergy.\n* Children presenting any type of cognitive or psychic disorder\n* Parents or legal tutors in which their future collaboration may not be the required, seen from the researchers' point of view."}, 'identificationModule': {'nctId': 'NCT05249166', 'acronym': 'ALINFA', 'briefTitle': 'Feeding for Accesible, Affordable and Healthy Childhood', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Feeding for Accesible, Affordable and Healthy Childhood', 'orgStudyIdInfo': {'id': 'ALINFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Subjects assigned to this arm will follow the habitual recommendations to develop skills for a healthy diet. No specific foods or cooking methods will be applied', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'ALINFA group', 'description': 'This group will receive, in addition to the usual recommendations, meals, and foods designed to increase the healthiness of the diet. Foods and meals have been designed to increase the fiber content, decrease sugars and saturated fats, and limit salt intake.', 'interventionNames': ['Other: ALINFA']}], 'interventions': [{'name': 'ALINFA', 'type': 'OTHER', 'description': 'Comparing the usual recommendations with the healthy diet designed and developed', 'armGroupLabels': ['ALINFA group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'control group', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Center for Nutrition Research. University of Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Santiago Navas Carretero, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Pública de Navarra', 'class': 'OTHER'}, {'name': 'Gobierno de Navarra', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}