Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-02-02 @ 1:45 PM
Study NCT ID:
NCT02923050
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simple Suppers Scale-up (S3)
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-01', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-10-01', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child standardized body mass index (BMI)', 'timeFrame': 'Change from baseline child BMI at 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '31823753', 'type': 'DERIVED', 'citation': 'Gunther C, Rogers C, Holloman C, Hopkins LC, Anderson SE, Miller CK, Copeland KA, Dollahite JS, Pratt KJ, Webster A, Labyk AN, Penicka C. Child diet and health outcomes of the simple suppers program: a 10-week, 2-group quasi-experimental family meals trial. BMC Public Health. 2019 Dec 10;19(1):1657. doi: 10.1186/s12889-019-7930-7.'}, {'pmid': '28069006', 'type': 'DERIVED', 'citation': 'Rogers C, Anderson SE, Dollahite JS, Hill TF, Holloman C, Miller CK, Pratt KJ, Gunther C. Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial. BMC Public Health. 2017 Jan 9;17(1):50. doi: 10.1186/s12889-016-3908-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.\n\nExclusion Criteria:\n\n* Family member: Following a restrictive or therapeutic diet.'}, 'identificationModule': {'nctId': 'NCT02923050', 'briefTitle': 'Simple Suppers Scale-up (S3)', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status', 'orgStudyIdInfo': {'id': '2014B0494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waitlist control'}, {'type': 'EXPERIMENTAL', 'label': '10-week family meals program', 'interventionNames': ['Behavioral: Simple Suppers']}], 'interventions': [{'name': 'Simple Suppers', 'type': 'BEHAVIORAL', 'description': 'Theory-based 10-week family meals program', 'armGroupLabels': ['10-week family meals program']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardinal Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carolyn Gunther', 'investigatorAffiliation': 'Ohio State University'}}}}