Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT03400566
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2018-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Experiential Learning on Vegetable Intake in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D005518', 'term': 'Food Preferences'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062525', 'term': 'Narrative Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intake of the target vegetable', 'timeFrame': 'Change in intake of the target vegetable from Baseline to day 14', 'description': 'Intake of the novel vegetable will be measured at baseline (day 1) and post intervention (day 14). Intake of the novel vegetable will be measured individually and objectively using weight in grams. Change in intake will be calculated by subtraction of baseline intake from post intervention intake.'}], 'secondaryOutcomes': [{'measure': 'Knowledge of the target vegetable', 'timeFrame': 'Knowledge of the target vegetable at day 14 (post intervention)', 'description': "Children's knowledge of the target vegetable will be assessed at baseline (day 1) and post intervention (day 14). Children will be asked to name the photo card featuring the target vegetable."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Habits', 'Food Preferences', 'Health Behavior', 'Diet Habit', 'Child Behavior']}, 'referencesModule': {'references': [{'pmid': '31378648', 'type': 'DERIVED', 'citation': 'Nekitsing C, Blundell-Birtill P, Cockroft JE, Fildes A, Hetherington MM. Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2014-2027. doi: 10.1016/j.jand.2019.05.017. Epub 2019 Aug 1.'}, {'pmid': '31378647', 'type': 'DERIVED', 'citation': 'Nekitsing C, Blundell-Birtill P, Cockroft JE, Hetherington MM. Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2004-2013. doi: 10.1016/j.jand.2019.05.012. Epub 2019 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).', 'detailedDescription': "The aim of this study is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years). In particular, the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters.\n\nThere are two manipulations in this study - the provision of a story which features either a target vegetable (celeriac) or a control vegetable (carrot) and the presence of experiential learning (smelling, touching, looking at the vegetable) with either the target vegetable or the control vegetable.\n\nBaseline consumption and familiarity of the target veg will be assessed for all children, before the intervention. The intervention consists of two familiarization trials, and 2-weeks of access to a story book featuring vegetables. Following the final familiarization trial, consumption and familiarity will be assessed again. Each familiarization trial consists of a story in class, and depending on condition, an experiential learning episode in class. During the 2 week interval between familiarization sessions nurseries will be requested to ready the story book 5 times in the preschool room (at times convenient to them).\n\nParticipants will be cluster randomized into 4 groups (2X2 between subjects design): 1) target vegetable narrative, 2) target vegetable narrative + experiential, 3) control vegetable narrative 4) control vegetable narrative + experiential\n\nChild's food fussiness data will be collected by parents using the Food Fussiness sub scale of the Child Eating Behaviour Questionnaire. Their usual consumption of the target vegetable will also be measured using parent report.\n\nNursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.\n\nIt is predicted that children's intake of the novel vegetable will vary by intervention. The primary hypothesis to be tested is that providing experience of a target novel vegetable within the context of an interactive story time will encourage preschoolers to taste, try and eat the target vegetable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 to 5 years old\n* Attends nursery on selected test day\n\nExclusion Criteria:\n\n* Relevant food allergy (celeriac / celery)\n* Medical condition which would prevent them from eating the test vegetable'}, 'identificationModule': {'nctId': 'NCT03400566', 'briefTitle': 'Effects of Experiential Learning on Vegetable Intake in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Effects of Congruent and In-congruent Experiential Learning on Intake of a Novel Vegetable in Preschool Children', 'orgStudyIdInfo': {'id': 'ULeeds'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Narrative (target)', 'description': 'Children will receive the story featuring the target vegetable and NO sensory experience.', 'interventionNames': ['Behavioral: Narrative']}, {'type': 'EXPERIMENTAL', 'label': 'Narrative+ experiential (target)', 'description': 'Children will receive the story featuring the target vegetable and experiential learning with the target vegetable.', 'interventionNames': ['Behavioral: Narrative', 'Behavioral: Experiential']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narrative (control)', 'description': 'Children will receive the story featuring the control vegetable and NO sensory experience.', 'interventionNames': ['Behavioral: Narrative']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narrative+ experiential (control)', 'description': 'Children will receive the story featuring the control vegetable and experiential learning with the control vegetable.', 'interventionNames': ['Behavioral: Narrative', 'Behavioral: Experiential']}], 'interventions': [{'name': 'Narrative', 'type': 'BEHAVIORAL', 'description': 'Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).', 'armGroupLabels': ['Narrative (control)', 'Narrative (target)', 'Narrative+ experiential (control)', 'Narrative+ experiential (target)']}, {'name': 'Experiential', 'type': 'BEHAVIORAL', 'description': 'Children will receive hands on experience with the vegetable. They will get to listen, see, feel, touch and smell the actual vegetable during the two familiarization phases.', 'armGroupLabels': ['Narrative+ experiential (control)', 'Narrative+ experiential (target)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9JT', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'School of Psychology, University of Leeds', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Chandani Nekitsing, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Economic and Social Research Council, United Kingdom', 'class': 'OTHER'}, {'name': 'Purely Nutrition Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Research Student', 'investigatorFullName': 'Chandani Nekitsing', 'investigatorAffiliation': 'University of Leeds'}}}}