Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00635518
Status:
WITHDRAWN
Last Update Posted:
2021-08-24
First Post:
2008-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D019959', 'term': 'Feeding and Eating Disorders of Childhood'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study Withdrawn'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding was canceled and no resources are available.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2008-03-05', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Plan Implementation', 'Feeding and Eating Disorders of Childhood', 'Breast Feeding', 'Overweight', 'Child', 'Infant Nutrition Physiology', 'Public Health'], 'conditions': ['Breast Feeding']}, 'descriptionModule': {'briefSummary': 'A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.', 'detailedDescription': 'A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".\n\nPregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All pregnant women in the last quarter of the gestation.\n\nExclusion Criteria:\n\n* HIV-positive mothers\n* congenital malformation'}, 'identificationModule': {'nctId': 'NCT00635518', 'briefTitle': 'Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'officialTitle': 'Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants', 'orgStudyIdInfo': {'id': 'vitolo1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'I, Intervention', 'interventionNames': ['Behavioral: Ten Steps for Healthy Feeding children programme']}], 'interventions': [{'name': 'Ten Steps for Healthy Feeding children programme', 'type': 'BEHAVIORAL', 'otherNames': ['Infant Nutrition Programme'], 'description': 'Ten Steps for Healthy Feeding children', 'armGroupLabels': ['I, Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Márcia R Vitolo, postdoctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Health Sciences of Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marcia Regina Vitolo', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}}