Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-22 @ 4:50 PM
Study NCT ID:
NCT03324568
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helping Young Children Improve Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019959', 'term': 'Feeding and Eating Disorders of Childhood'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral Pediatrics Feeding Assessment', 'timeFrame': '4 weeks', 'description': 'Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.'}], 'secondaryOutcomes': [{'measure': 'Food Frequency Questionnaire', 'timeFrame': '4 weeks', 'description': 'Parent questionnaire that measures the amount of different foods children ate over a specific time period (e.g. one month). A higher score indicates more different foods were consumed by the child.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding and Eating Disorders of Childhood']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey.\n\nExclusion Criteria:\n\n* Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.'}, 'identificationModule': {'nctId': 'NCT03324568', 'briefTitle': 'Helping Young Children Improve Eating', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Helping Young Children Improve Eating', 'orgStudyIdInfo': {'id': 'IRB17-00420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Educational handout', 'interventionNames': ['Behavioral: Educational Handout']}, {'type': 'EXPERIMENTAL', 'label': 'Video plus educational handout', 'interventionNames': ['Behavioral: Parent Education Videos', 'Behavioral: Educational Handout']}], 'interventions': [{'name': 'Parent Education Videos', 'type': 'BEHAVIORAL', 'description': 'Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.', 'armGroupLabels': ['Video plus educational handout']}, {'name': 'Educational Handout', 'type': 'BEHAVIORAL', 'description': 'Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.', 'armGroupLabels': ['Educational handout', 'Video plus educational handout']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not yet decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kelly Tanner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kelly Tanner', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}