Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-24 @ 4:52 PM
Study NCT ID:
NCT03138551
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single-Case Experimental Design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Acceptance', 'timeFrame': '30 meals video recorded throughout study participation (10 per phase, 1 month)', 'description': 'Significant change in percentage of targeted food accepted between phases.'}], 'secondaryOutcomes': [{'measure': '3-Day Food Diary', 'timeFrame': 'Baseline through Study Completion (1 month)', 'description': 'Increased number of foods eaten over a three-day period.'}, {'measure': 'Behavioral Pediatric Feeding Assessment (BPFAS)', 'timeFrame': 'Baseline through Study Completion (1 month)', 'description': 'Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sensory Food Aversions'], 'conditions': ['Feeding Disorder of Infancy or Early Childhood']}, 'referencesModule': {'references': [{'pmid': '30760395', 'type': 'DERIVED', 'citation': 'Caldwell AR, Skidmore ER, Raina KD, Rogers JC, Terhorst L, Danford CA, Bendixen RM. Behavioral Activation Approach to Parent Training: Feasibility of Promoting Routines of Exploration and Play During Mealtime (Mealtime PREP). Am J Occup Ther. 2018 Nov/Dec;72(6):7206205030p1-7206205030p8. doi: 10.5014/ajot.2018.028365.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.', 'detailedDescription': 'This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child must meet all criteria of the diagnosis of Sensory Food Aversions\n\n 1. The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.\n 2. Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).\n 3. The child eats without difficulty when offered preferred foods.\n 4. The food refusal causes specific nutritional deficiencies or delay of oral motor development.\n* Parent is able to read, write, speak and understand English.\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT03138551', 'briefTitle': 'Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions', 'orgStudyIdInfo': {'id': 'PRO15060533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mealtime PREP', 'description': 'Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases.\n\nA: Baseline - typical mealtimes in the home.\n\nB: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention.\n\nB-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.', 'interventionNames': ['Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play)']}], 'interventions': [{'name': 'Mealtime PREP (Promoting Routines of Exploration and Play)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mealtime PREP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Angela R Caldwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is currently no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Angela Caldwell', 'investigatorAffiliation': 'University of Pittsburgh'}}}}