Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT04127812
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2019-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating a Mindful Eating Curriculum, "Savor the Flavor"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Selected classrooms will receive the Savor the Flavor intervention. Data will be collected prior to and after the intervention. Children, their parent/guardian, and classroom teachers will participate in the research.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child body mass index', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Child height and weight will be measured and used to calculate body mass index (BMI). Age and sex specific BMI percentiles/z-scores will be calculated using CDC growth standards'}, {'measure': 'Child Eating Behavior Questionnaire', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Parents will complete the Child Eating Behavior Questionnaire as part of a survey packet'}, {'measure': 'Structure and Control in Parent Feeding', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Parents will complete the Structure and Control in Parent Feeding as part of a survey packet'}, {'measure': 'USDA Food Security questionnaire', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Parents will complete the USDA food security questionnaire as part of a survey packet'}, {'measure': 'External Food Responsiveness scale', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Parents will complete the External Food Responsiveness Scale as part of a survey packet'}, {'measure': 'Eating in the Absence of Hunger scale', 'timeFrame': 'Measured once at any time between enrollment and conclusion of 5 week intervention', 'description': 'Parents will complete the Eating in the Absence of Hunger Scale as part of a survey packet'}], 'primaryOutcomes': [{'measure': 'Change in eating in the absence of hunger from pre to post intervention', 'timeFrame': 'Pre intervention and at conclusion of 5 week intervention', 'description': 'Children will be given seven minutes of free access to a variety of palatable snacks and toys during a time when they are not hungry (e.g. after a meal). Intake of snacks is determined by pre and post weighing the foods.'}], 'secondaryOutcomes': [{'measure': 'Recall of Savor the Flavor steps', 'timeFrame': 'At conclusion of 5 week intervention', 'description': 'Children will be asked to recall the five steps of "Savor the Flavor"'}, {'measure': 'Acceptability of intervention', 'timeFrame': 'At conclusion of 5 week intervention', 'description': 'Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfullness', 'eating', 'snacking', 'obesity', 'children'], 'conditions': ['Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.', 'detailedDescription': 'The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. The goal of this curriculum is to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention will also teach children attention control techniques so that they are better able to delay consumption of high energy, low nutrition foods, when appropriate.The study will also evaluate a modified version of the Eating in the Absence of Hunger task for use in a preschool classroom setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Child Inclusion Criteria:\n\n* Child must be enrolled in a Head Start preschool center\n* Child must be between the ages of 2 and 6 years old\n\nChild Exclusion Criteria:\n\n* Food allergy or restriction to foods included in protocol\n\nParent Inclusion Criteria:\n\n* Parent or other primary caregiver of a child enrolled in the study\n* 18 years of age or older\n* English speaking\n\nParent Exclusion Criteria:\n\n\\- None\n\nTeacher Inclusion Criteria:\n\n* Actively employed as an early childhood education provider in the Head Start classroom where intervention is delivered\n* 18 years of age or older\n\nTeacher Exclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT04127812', 'briefTitle': 'Evaluating a Mindful Eating Curriculum, "Savor the Flavor"', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Evaluating a Mindful Eating Curriculum, "Savor the Flavor" to Promote Healthy Eating Among Head Start Preschool Children', 'orgStudyIdInfo': {'id': 'STUDY00013064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Savor the Flavor', 'description': 'The "Savor the Flavor" curriculum is a series of five interactive lessons designed to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention also teaches attention control techniques so that children are better able to delay consumption of high energy, low nutrition foods, when appropriate, as well as general mindfulness practices (e.g. breathing exercises). Lessons are delivered in the Head Start classroom by a nutrition educator.', 'interventionNames': ['Behavioral: Savor the Flavor']}], 'interventions': [{'name': 'Savor the Flavor', 'type': 'BEHAVIORAL', 'description': 'A series of five interactive classroom lessons focused on mindfulness in eating.', 'armGroupLabels': ['Savor the Flavor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Jennifer S Savage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available after publication of primary outcomes.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be available from the principal investigator upon request.', 'accessCriteria': "Access requests will be evaluated and approved at the principal investigator's discretion."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Savage Williams', 'investigatorAffiliation': 'Penn State University'}}}}