Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-28 @ 8:23 PM
Study NCT ID:
NCT03338257
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Husky Reads Effectiveness in Increasing Produce Preference and Food Group Identification in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The evaluation follows a pre-test/post-test control group design with children nested within classrooms at center and school-based early care programs located in low-income communities or areas with high SNAP eligibility rates'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of MyPlate', 'timeFrame': 'Three week post 10-week intervention', 'description': 'Ability to name MyPlate (Larsen et al)'}, {'measure': 'Ability to place foods in MyPlate food groups', 'timeFrame': 'Three week post 10-week intervention', 'description': 'Measured by using the Food Group Game, informed by Building a Healthy Me! evaluation survey. (Larsen et al.)'}, {'measure': 'Identification of specified fruits and vegetables', 'timeFrame': 'Three week post 10-week intervention', 'description': 'Identification using modified Carraway-Stage protocol'}, {'measure': 'Preference for specified fruits and vegetables', 'timeFrame': 'Three week post 10-week intervention', 'description': 'Fruit and vegetable liking as measured by modified Carraway-Stage protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-school children', 'fruit and vegetable acceptance', 'service-learning', 'pre-school nutrition education', 'childhood obesity'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '24365199', 'type': 'BACKGROUND', 'citation': 'Carraway-Stage V, Spangler H, Borges M, Goodell LS. Evaluation of a pictorial method to assess liking of familiar fruits and vegetables among preschool children. Appetite. 2014 Apr;75:11-20. doi: 10.1016/j.appet.2013.12.011. Epub 2013 Dec 21.'}, {'pmid': '27917488', 'type': 'BACKGROUND', 'citation': 'Larsen AL, Liao Y, Alberts J, Huh J, Robertson T, Dunton GF. RE-AIM Analysis of a School-Based Nutrition Education Intervention in Kindergarteners. J Sch Health. 2017 Jan;87(1):36-46. doi: 10.1111/josh.12466.'}]}, 'descriptionModule': {'briefSummary': 'Since 1998, UCONN undergraduate students have volunteered as part of a service- learning course to deliver a program called Husky Reads. Inspired by the nationally accepted American Academy of Pediatrics\' program "Reach Out and Read," Husky Reads was first designed for promotion of health, nutrition habits and literacy by reading health-oriented books to young children in pediatric and health clinics. The Husky Reads curriculum now includes a series of 10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and vegetable literacy. Undergraduate students enrolled in the Husky Reads service- learning course at UConn or college students participating in the paid summer internship program deliver the preschool lessons. Each team of 2-3 undergraduate students is assigned 2-3 early care classrooms to visit and deliver Husky Reads lessons to on a weekly basis. This series targets children at an early age because early childhood is a pivotal time to influence the path towards healthy behaviors and away from obesity. The effectiveness of the Husky Reads curriculum on a preschool age child\'s correct identification and liking of fruits and vegetables has not been established. The proposed evaluation uses a pre-test/post- test control group design with paired data at the child level to explore whether children who participate in Husky Reads have increased odds of correctly identifying the United States Department of Agriculture (USDA) "MyPlate" program (MyPlate) and food group concepts and trying or liking select fruits and vegetables.', 'detailedDescription': 'Since 1998, University of Connecticut (UCONN) undergraduate students have volunteered as part of a service- learning course to deliver a program called Husky Reads. Inspired by the nationally accepted American Academy of Pediatrics\' program "Reach Out and Read," Husky Reads was first designed for promotion of health, nutrition habits and literacy by reading health-oriented books to young children in pediatric and health clinics. The Husky Reads curriculum now includes a series of 10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and vegetable literacy. Each lesson includes reading at least one children\'s book, an activity or game, and food tasting to complement learning objectives related to MyPlate and fruit/vegetable literacy. Undergraduate students enrolled in the Husky Reads service- learning course at UConn or college students participating in the paid summer internship program deliver the preschool lessons. Each team of 2-3 undergraduate students is assigned 2-3 early care classrooms to visit and deliver Husky Reads lessons to on a weekly basis. This series targets children at an early age because early childhood is a pivotal time to influence the path towards healthy behaviors and away from obesity. Providing food tastings and increasing exposure to foods like fruits and vegetables is especially relevant because food preferences are developed in early childhood. Early childhood is also an important time for introducing healthy behaviors because once obesity is established in childhood; it often tracks through to adulthood and is difficult to reverse through interventions.\n\nThe effectiveness of the Husky Reads curriculum on a preschool age child\'s MyPlate knowledge and correct identification and liking of fruits and vegetables has not been established. A more comprehensive evaluation is needed to establish if the program is effective and contributes to quality improvement efforts. Findings from a prior evaluation suggest the ability of preschoolers to identify blueberries, strawberries, carrots and broccoli increased significantly after participation in one Husky Reads lesson. Although the findings were promising, the evaluation design lacked a control group and relied on a classroom wide assessment with hands raised as a response rather than measuring whether the ability to identify the produce items changed for a given child after participation in Husky Reads. Therefore, a more thorough evaluation of whether Husky Reads helps children learn to identify select fruits and vegetables is still needed. Questions also remain whether Husky Reads increases the odds of a child tasting and/or liking select fruits and vegetables as well as recognition of MyPlate and foods in different food groups. The proposed evaluation uses a pre-test/post- test control group design with paired data at the child level to explore whether children who participate in Husky Reads have increased odds of identifying MyPlate and food group concepts , and correctly identifying,trying or liking select fruits and vegetables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '35 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child attending center or school based early care with high family enrollment in Supplemental Nutrition Assistance (SNAP)\n\nExclusion Criteria:\n\n* child whose parent has signed the "opt out" portion of the notification form.'}, 'identificationModule': {'nctId': 'NCT03338257', 'briefTitle': 'Husky Reads Effectiveness in Increasing Produce Preference and Food Group Identification in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Husky Reads Evaluation: Measuring Changes in Fruit and Vegetable Recognition and Liking', 'orgStudyIdInfo': {'id': '17-069-3'}, 'secondaryIdInfos': [{'id': '601305', 'type': 'OTHER_GRANT', 'domain': 'CT Department of Social Services/USDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Husky Reads Intervention', 'description': "The Husky Reads curriculum includes a series of 10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and vegetable literacy. Each lesson includes reading at least one children's book, an activity or game, and sometimes food tasting to complement the learning objectives. Undergraduate students enrolled in the Husky Reads service-learning course at UCONN or college students participating in a paid summer internship deliver the program. Each team of 2-3 students is assigned 2-3 early care classrooms to visit and deliver Husky Reads on a weekly basis.", 'interventionNames': ['Behavioral: Husky Reads Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list Control', 'description': 'Programs on the wait list for Husky Reads, participate in the pre and post intervention testing but do not receive the program.'}], 'interventions': [{'name': 'Husky Reads Intervention', 'type': 'BEHAVIORAL', 'description': "The Husky Reads curriculum now includes a series of 10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and vegetable literacy. Each lesson includes reading at least one children's book, an activity or game, and food tasting to complement learning objectives related to MyPlate and fruit/vegetable literacy. Undergraduate students enrolled in the Husky Reads service- learning course at UConn or college students participating in the paid summer internship program deliver the preschool lessons. Each team of 2-3 undergraduate students is assigned 2-3 early care classrooms to visit and deliver Husky Reads lessons to on a weekly basis.", 'armGroupLabels': ['Husky Reads Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Ann m Ferris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}, {'name': 'Erin Havens, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UConn Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This group will share raw data with developer of testing instrument.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}