Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT05881759
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Food Rx With Best Feeding Practices With EFNEP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in feeding practices at 3-months will be assessed using the Food Parenting Inventory', 'timeFrame': 'baseline and post-intervention at 3-months', 'description': 'Feeding practices will be assessed using the Food Parenting Inventory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Habits', 'Childhood Obesity', 'Food Selection', 'Feeding Behavior']}, 'descriptionModule': {'briefSummary': 'To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.', 'detailedDescription': 'The purpose of the pilot study is to test the FFYF feeding curriculum material and procedures for implementation, staff training, recruitment, and data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in Harris or Fort Bend counties\n* being a parent of a child 4-8 years old\n* ability to speak in English or Spanish\n* have ready access to a telephone\n* have access to the Internet with a smart phone, a tablet, a laptop, or a desktop computer\n\nExclusion Criteria:\n\n* parents of children with disabilities and/or those on prescription medications that affect weight and/or appetite\n* parents who are not able to complete self-report questionnaires'}, 'identificationModule': {'nctId': 'NCT05881759', 'briefTitle': 'Integrating Food Rx With Best Feeding Practices With EFNEP', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Integrating Food Rx With Best Feeding Practices for Chronic Disease Prevention Among EFNEP Participants', 'orgStudyIdInfo': {'id': 'H-50824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Practice - ESBA', 'description': 'The control group sites will receive the existing ESBA curriculum which is their usual practice.'}, {'type': 'EXPERIMENTAL', 'label': 'ESBA + Feeding Practices', 'description': 'The intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols.', 'interventionNames': ['Behavioral: Revised ESBA']}], 'interventions': [{'name': 'Revised ESBA', 'type': 'BEHAVIORAL', 'description': "Four intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols. Two of the four intervention sites will also participate in the Food Rx program. The control group sites will receive the existing ESBA curriculum. All program materials will be available in English and Spanish. Study participation will be maintained via weekly phone calls/text messaging by the Extension staff. For the online feeding practices content, participants will receive messages to visit the project website and watch the videos, participate in online activities, and engage in facilitated online discussions. For the Food Rx arm, participants will receive a 'Food Rx' card for bi-weekly redemption of \\~30 lbs of fresh produce, plus whole grains, lean protein and low-fat dairy at a co-located Houston Food Bank food pantry. The prescription will be eligible for redemption every two weeks for 3 months, for a total of 6 redemptions.", 'armGroupLabels': ['ESBA + Feeding Practices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jayna Dave, PhD', 'role': 'CONTACT', 'email': 'jmdave@bcm.edu', 'phone': '713-798-7195'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jayna Dave, PhD', 'role': 'CONTACT', 'email': 'jmdave@bcm.edu', 'phone': '7137987195'}, {'name': 'Mamie White, MS', 'role': 'CONTACT', 'email': 'mawhite@bcm.edu', 'phone': '71379890501'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prairie View A&M University', 'class': 'OTHER'}, {'name': 'University of Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jayna Dave', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}