Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-29 @ 7:46 PM
Study NCT ID:
NCT06072651
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mother-Baby Study - Relative Reinforcing Value (RRV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Reinforcing Value (RRV) of food', 'timeFrame': 'Up to approximately 36 months', 'description': 'The RRV is measured using the number of button presses for each reward type relative to other reward types'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eating behavior'], 'conditions': ['Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.\n\nTo participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.', 'detailedDescription': 'This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 300 participants (150 mothers and 150 children). In this trial only data from the children is collected and therefore only 150 participants are listed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'The child is a participant in the observational study (NCT06039878).'}, 'identificationModule': {'nctId': 'NCT06072651', 'briefTitle': 'Mother-Baby Study - Relative Reinforcing Value (RRV)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad', 'orgStudyIdInfo': {'id': 'HUM00227836 CT2'}, 'secondaryIdInfos': [{'id': 'R01DK134979', 'link': 'https://reporter.nih.gov/quickSearch/R01DK134979', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relative Reinforcing Value', 'description': 'The researchers will enroll 150 children from the long-term observational study, NCT06039878.', 'interventionNames': ['Behavioral: Relative Reinforcing Value of Food']}], 'interventions': [{'name': 'Relative Reinforcing Value of Food', 'type': 'BEHAVIORAL', 'description': 'Researcher gives child opportunity to press a button to earn three types of rewards: a high-reward food, a low-reward food, and a non-food reward.', 'armGroupLabels': ['Relative Reinforcing Value']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Jeanpierre', 'role': 'CONTACT', 'email': 'ajeanp@umich.edu', 'phone': '734-531-9869'}, {'name': 'Julie Lumeng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Alex Jeanpierre', 'role': 'CONTACT', 'email': 'ajeanp@umich.edu', 'phone': '734-531-9869'}], 'overallOfficials': [{'name': 'Julie Lumeng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics', 'investigatorFullName': 'Julie Lumeng', 'investigatorAffiliation': 'University of Michigan'}}}}