Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 5:56 PM
Study NCT ID:
NCT05341960
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005378', 'term': 'Financial Support'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-19', 'size': 334264, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-15T18:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Insecurity', 'timeFrame': 'Change from baseline to 10 weeks post-randomization', 'description': '6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome'}, {'measure': 'Food Insecurity', 'timeFrame': 'Change from baseline to delivery', 'description': '6 item, USDA measure; dichotomous outcome'}, {'measure': 'Maternal depression', 'timeFrame': 'Change from baseline to 10 weeks post-randomization', 'description': '9 item, self-administered, assesses maternal depression'}, {'measure': 'Maternal depression', 'timeFrame': 'Change from baseline to delivery', 'description': '9 item, self-administered, assesses maternal depression'}, {'measure': 'Social Support', 'timeFrame': 'Change from baseline to 10 weeks post-randomization', 'description': '6 item, self-administered, assesses emotional and instrumental social support'}, {'measure': 'Social Support', 'timeFrame': 'Change from baseline to delivery', 'description': '6 item, self-administered, assesses emotional and instrumental social support'}, {'measure': 'Mastery', 'timeFrame': 'Change from baseline to 10 weeks post-randomization', 'description': '7 item, self-administered, assesses skill development and locus of control'}, {'measure': 'Mastery', 'timeFrame': 'Change from baseline to delivery', 'description': '7 item, self-administered, assesses skill development and control'}, {'measure': 'Baby Birthweight', 'timeFrame': 'At delivery', 'description': "Baby's birthweight, measured in grams"}, {'measure': 'Baby Gestational Age', 'timeFrame': 'At delivery', 'description': "Baby's gestational age at birth, measured in weeks"}, {'measure': 'Neonatal Intensive Care (NICU) Utilization', 'timeFrame': 'From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months', 'description': 'number of days baby was admitted to NICU'}, {'measure': 'Days Hospitalization', 'timeFrame': 'From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months', 'description': 'total number of days baby was hospitalized following birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Insecurity', 'Community Health Workers', 'Food Delivery', 'Prenatal Nutrition', 'Social Determinants of Health'], 'conditions': ['Pregnancy Related', 'Food Insecurity', 'Premature Birth', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '37586560', 'type': 'DERIVED', 'citation': 'Borawski EA, Goodwin MA, Glenn AC, Mundorf C, Fernandez LI, Larberg N, Gunzler DD, Lever JS. Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals. Contemp Clin Trials. 2023 Oct;133:107310. doi: 10.1016/j.cct.2023.107310. Epub 2023 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB', 'detailedDescription': 'The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (\\<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80).\n\nThe pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medicaid eligible\n* Enrolls in the CHW Hub\n* Able to read and understand English\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05341960', 'briefTitle': 'Nourishing Beginnings: Addressing Food Insecurity During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals', 'orgStudyIdInfo': {'id': 'STUDY20211072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food Delivery', 'description': 'Food box delivered to participant home every 2 weeks until 6 weeks post delivery', 'interventionNames': ['Behavioral: Food Delivery']}, {'type': 'EXPERIMENTAL', 'label': 'Financial Support and Navigation', 'description': '$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.', 'interventionNames': ['Other: Financial Support']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Selected from claims data, matched.'}], 'interventions': [{'name': 'Food Delivery', 'type': 'BEHAVIORAL', 'description': 'Food box with food to feed a family of four, delivered by the Greater Cleveland Food Bank every two weeks. Based on participant preferences, includes recipes.', 'armGroupLabels': ['Food Delivery']}, {'name': 'Financial Support', 'type': 'OTHER', 'description': 'Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.', 'armGroupLabels': ['Financial Support and Navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Solove', 'role': 'CONTACT', 'email': 'ksolove@clevelandohio.gov'}], 'facility': "Mom's First", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44113', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Mundorf, PHD', 'role': 'CONTACT'}], 'facility': 'Better Health Partnership CHW HUB', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Elaine A Borawski, PhD', 'role': 'CONTACT', 'email': 'exb11@case.edu', 'phone': '216-368-1024'}, {'name': 'Samantha Bentley, MPH', 'role': 'CONTACT', 'email': 'sxb1213@case.edu'}], 'overallOfficials': [{'name': 'Elaine A Borawski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Better Health Partnership', 'class': 'UNKNOWN'}, {'name': 'Greater Cleveland Food Bank', 'class': 'UNKNOWN'}, {'name': 'Pregnancy with Possibilities Resource Center', 'class': 'UNKNOWN'}, {'name': 'Village of Healing Center', 'class': 'UNKNOWN'}, {'name': 'United Way of Greater Cleveland', 'class': 'UNKNOWN'}, {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, {'name': 'Cleveland Department of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Angela Bowen Williamson Professor of Community Nutrition', 'investigatorFullName': 'Elaine Borawski', 'investigatorAffiliation': 'Case Western Reserve University'}}}}