Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-20 @ 3:31 PM
Study NCT ID:
NCT02766218
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2016-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mealtime Interactions and Risk of Toddler Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000078064', 'term': 'Gestational Weight Gain'}], 'ancestors': [{'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'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responsive feeding', 'timeFrame': '18- and 24-months', 'description': 'The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues.'}], 'secondaryOutcomes': [{'measure': 'Child Weight Status', 'timeFrame': 'birth, 6-, 12-, 18-, 24- and 36-months', 'description': 'zBMI will be computed at each time point'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['toddler obesity', 'responsive feeding', 'behavioral weight control', 'pregnancy weight gain', 'early life risk factors'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother participated in clinical trial #NCT01545934\n* Child 18-36 months old\n\nExclusion Criteria:\n\n* Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).'}, 'identificationModule': {'nctId': 'NCT02766218', 'briefTitle': 'Mealtime Interactions and Risk of Toddler Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Mealtime Interactions and Risk of Obesity in Toddlers', 'orgStudyIdInfo': {'id': '23356'}, 'secondaryIdInfos': [{'id': 'R01DK108661', 'link': 'https://reporter.nih.gov/quickSearch/R01DK108661', 'type': 'NIH'}, {'id': 'R56DK108661', 'link': 'https://reporter.nih.gov/quickSearch/R56DK108661', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Behavioral: Lifestyle Intervention', 'description': 'The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.'}, {'label': 'No Intervention: Standard Care'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chantelle Hart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}, {'name': 'Suzanne Phelan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Polytechnic State University-San Luis Obispo'}, {'name': 'Rena Wing, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Miriam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Miriam Hospital', 'class': 'OTHER'}, {'name': 'California Polytechnic State University-San Luis Obispo', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}