Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03400605
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2017-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire', 'timeFrame': 'birth to 6 months postpartum', 'description': 'Reported exclusive breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum', 'timeFrame': 'birth to 2 weeks postpartum', 'description': 'Reported started breastfeeding at birth in response to a prospective infant feeding questionnaire'}, {'measure': 'Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum', 'timeFrame': 'birth to 6 months', 'description': 'Reported length of breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire'}, {'measure': 'Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum', 'timeFrame': 'birth to 6 months', 'description': 'Reported timing of the introduction of complementary foods from birth to 6 months in response to a prospective infant feeding questionnaire'}, {'measure': 'Types of complementary foods introduced as assessed by responses to a prospective infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum', 'timeFrame': 'birth to 6 months', 'description': 'Reported types of foods introduced to infants from birth to 6 months in response to an infant feeding questionnaire'}, {'measure': 'Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum', 'timeFrame': 'birth to 6 months', 'description': 'Reported provision of vitamin or mineral supplementation to infants from birth to 6 months in response to a prospective infant feeding questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding', 'Breastfeeding, Exclusive', 'Infant Nutrition', 'Vulnerable Population', 'Complementary Feeding', 'Food Security']}, 'referencesModule': {'references': [{'pmid': '33658034', 'type': 'RESULT', 'citation': "Francis J, Mildon A, Stewart S, Underhill B, Ismail S, Di Ruggiero E, Tarasuk V, Sellen DW, O'Connor DL. Breastfeeding rates are high in a prenatal community support program targeting vulnerable women and offering enhanced postnatal lactation support: a prospective cohort study. Int J Equity Health. 2021 Mar 3;20(1):71. doi: 10.1186/s12939-021-01386-6."}, {'pmid': '35676013', 'type': 'DERIVED', 'citation': "Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, Kiss A, O'Connor DL, Sellen DW. Associations between use of expressed human milk at 2 weeks postpartum and human milk feeding practices to 6 months: a prospective cohort study with vulnerable women in Toronto, Canada. BMJ Open. 2022 Jun 8;12(6):e055830. doi: 10.1136/bmjopen-2021-055830."}], 'seeAlsoLinks': [{'url': 'https://equityhealthj.biomedcentral.com/articles/10.1186/s12939-021-01386-6', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada.\n\nThe aim of this project is to investigate the incidence, duration and exclusivity of breastfeeding and timely complementary feeding based on level of maternal participation in components of a pre and postnatal community outreach program. Exploring infant feeding practices is an evaluation component that will not only characterize infant feeding practices within a vulnerable population, but will elucidate whether there are areas of concern that need to be expanded upon within pre or postnatal programming. A prospective infant feeding questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months postpartum. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates will be observed among women who utilize provided postnatal services more readily."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Clients enrolled in Parkdale Parents' Primary Prevention Project (5P's) at Parkdale Community Health Centre in Toronto, Ontario, Canada.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally\n* Enrolled prenatally in 5P's as of August 17, 2017 onwards\n\nExclusion Criteria:\n\n* Only enrolled in Parkdale Parents' Primary Prevention Project (5P's) postnatally\n* Unavailable to participate in infant feeding questionnaire by telephone or in-person during 5P's programming"}, 'identificationModule': {'nctId': 'NCT03400605', 'acronym': 'PINSTEP-3', 'briefTitle': 'Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 3-Infant Feeding)', 'orgStudyIdInfo': {'id': '34482-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Program Clients', 'description': "Parkdale Parents' Primary Prevention Project (5P's) clients", 'interventionNames': ['Other: Infant feeding questionnaire']}], 'interventions': [{'name': 'Infant feeding questionnaire', 'type': 'OTHER', 'description': 'Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum', 'armGroupLabels': ['Program Clients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6R 3B2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Parkdale Community Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jane Francis, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniel Sellen', 'investigatorAffiliation': 'University of Toronto'}}}}