Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-13 @ 11:15 PM
Study NCT ID:
NCT02622035
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2015-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Technology and Child Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses', 'timeFrame': 'At lab visit', 'description': 'feeding behavior and self-reported outcomes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child Feeding'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '30395145', 'type': 'DERIVED', 'citation': 'Persky S, Ferrer RA, Klein WMP, Goldring MR, Cohen RW, Kistler WD, Yaremych HE, Bouhlal S. Effects of Fruit and Vegetable Feeding Messages on Mothers and Fathers: Interactions Between Emotional State and Health Message Framing. Ann Behav Med. 2019 Aug 16;53(9):789-800. doi: 10.1093/abm/kay088.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2016-HG-0026.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nWe are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.\n\nObjective:\n\n\\- To learn about technologies and approaches to use in future research studies.\n\nEligibility:\n\n\\- Parents (fathers and mothers) of children between the ages of 3-7.\n\nDesign:\n\nAs part of the main study, participants will do four tasks:\n\nTask 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.\n\nTask 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions\n\nTask 3: At the in-person visit, participants will read information about a child health topic and answer questions\n\nTask 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...', 'detailedDescription': 'Background:\n\nWe are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.\n\nObjective:\n\n\\- To learn about technologies and approaches to use in future research studies.\n\nEligibility:\n\n\\- Parents (fathers and mothers) of children between the ages of 3-7.\n\nDesign:\n\nAs part of the main study, participants will do four tasks:\n\nTask 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.\n\nTask 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions\n\nTask 3: At the in-person visit, participants will read information about a child health topic and answer questions\n\nTask 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA - MAIN TRIAL\n* All participants in the main trial will be healthy adult parents 18 years and older\n* Inclusion criteria include:\n\n 1. being the parent of a biological child who is between 4 and 7 years old with no major allergies or dietary-related health conditions;\n 2. having some responsibility for child s dietary intake ;\n 3. having the ability to read, write, and converse in English;\n 4. being able to come to the NIH Clinical Center for one visit.\n\nEXCLUSION CRITERIA - MAIN TRIAL\n\n* Exclusion criteria include:\n\n 1. having received information about the study purpose;\n 2. being an NHGRI employee;\n 3. being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.\n\n EXCLUSION CRITERIA - VIRTUAL REALITY\n* Exclusion criteria related to use of the virtual reality environment include:\n\n 1. having a medical susceptibility to dizziness, disorientation or nausea;\n 2. having a seizure disorder or epilepsy;\n 3. having a high propensity for motion sickness;\n 4. lacking freedom of movement;\n 5. known pregnancy;\n 6. low, uncorrected vision and hearing.\n\nINCLUSION CRITERIA - PILOT\n\n* Participants in the Pilot test will be healthy adult parents 18 years and older.\n* Inclusion criteria include:\n\n 1. being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions, but only for the first 10 participants;\n 2. having the ability to read, write, and converse in English;\n 3. being able to come to the NIH Clinical Center for one visit.\n\nEXCLUSION CRITERIA - PILOT\n\n1. having received information about the study purpose;\n2. being an NHGRI employee;\n3. low, uncorrected vision and hearing.\n\nINCLUSION CRITERIA - BUFFET SERVING EVALUATION\n\n* Participants in the secondary Buffet Serving Evaluation will be healthy adult parents 18 years and older\n* Inclusion criteria include:\n\n 1. being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions;\n 2. having some responsibility for child s dietary intake ;\n 3. having the ability to read, write, and converse in English;\n 4. being able to come to the NIH Clinical Center for one visit.\n\nEXCLUSION CRITERIA - BUFFET SERVING EVALUATION (MAIN)\n\n1. being an NHGRI employee;\n2. being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.\n\nEXCLUSION CRITERIA - BUFFET SERVING EVALUATION (VIRTUAL REALITY)\n\n* Exclusion criteria related to use of the virtual reality environment include:\n\n 1. having a medical susceptibility to dizziness, disorientation or nausea;\n 2. having a seizure disorder or epilepsy;\n 3. having a high propensity for motion sickness;\n 4. lacking freedom of movement;\n 5. known pregnancy;\n 6. low, uncorrected vision and hearing.\n\n INCLUSION CRITERIA- OLFACTORY AWARENESS TEST:\n* Participants in the Olfactory Awareness Test will be healthy adults between the ages of 18 and 59\n\nInclusion criteria include:\n\n1. Having the ability to read, write and converse in English\n2. Able to come to the clinical center for on visit.\n\nWe may also include the following inclusion criteria:\n\n1. Being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions\n2. Having some responsibility for child s dietary intake; however, if we encounter recruitment difficulties, we may instead sample nonparent participants who are of the same general age range as parents who participated in our past studies using the virtual buffet. For the pilot test, we will sample non-parents in the age range of past parent participants\n\nEXCLUSION CRITERIA-OLFACTORY AWRAENESS TEST:\n\n1. Being an NHGRI employee;\n2. Having participated in the Parents TAKE study conducted previously in this lab.\n\nExclusion criteria related to use of the virtual reality environment include:\n\n1. Having a medical susceptibility to dizziness, disorientation or nausea;\n2. Having a seizure disorder or epilepsy;\n3. Having a high propensity for motion sickness;\n4. Lacking freedom of movement;\n5. Known pregnancy;\n6. Weak, uncorrected vision, hearing, and/or smell. No adults older than age 59 will be able to participate in this study because older adults tend to experience a decline in olfactory function'}, 'identificationModule': {'nctId': 'NCT02622035', 'briefTitle': 'New Technology and Child Health', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'New Technology and Child Health', 'orgStudyIdInfo': {'id': '160026'}, 'secondaryIdInfos': [{'id': '16-HG-0026'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Gain frame; Anger', 'interventionNames': ['Behavioral: Provision of information', 'Behavioral: Emotion induction']}, {'type': 'EXPERIMENTAL', 'label': '1b', 'description': 'high visual perceptual load high interactive', 'interventionNames': ['Behavioral: visual perceptual load']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Gain frame; Fear', 'interventionNames': ['Behavioral: Provision of information', 'Behavioral: Emotion induction']}, {'type': 'EXPERIMENTAL', 'label': '2b', 'description': 'high visual perceptual load', 'interventionNames': ['Behavioral: visual perceptual load']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Loss frame; Anger', 'interventionNames': ['Behavioral: Provision of information', 'Behavioral: Emotion induction']}, {'type': 'EXPERIMENTAL', 'label': '3b', 'description': 'low visual perceptual load', 'interventionNames': ['Behavioral: visual perceptual load']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Loss frame; Fear', 'interventionNames': ['Behavioral: Provision of information', 'Behavioral: Emotion induction']}], 'interventions': [{'name': 'Provision of information', 'type': 'BEHAVIORAL', 'description': 'Information about fruit and vegetable feeding for children framed in gain vs. loss manner', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'Emotion induction', 'type': 'BEHAVIORAL', 'description': 'Film clip designed to induce anger or fear', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'visual perceptual load', 'type': 'BEHAVIORAL', 'description': 'visual and interactivity-based load of virtual reality buffet environment', 'armGroupLabels': ['1b', '2b', '3b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Susan Persky, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Human Genome Research Institute (NHGRI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data set is not currently deidentified and participants were not consented for data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}