Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT02052518
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Childhood Obesity Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of months of breast feeding', 'timeFrame': '6 and 12 months', 'description': 'Number of months that child is breastfed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Childhood obesity', 'Breastfeeding', 'Introduction of solids', 'Introduction of juice'], 'conditions': ['Body Weight Changes']}, 'referencesModule': {'references': [{'pmid': '26104068', 'type': 'DERIVED', 'citation': 'Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): an ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health. 2015 Jun 24;15:584. doi: 10.1186/s12889-015-1897-9.'}]}, 'descriptionModule': {'briefSummary': 'This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).', 'detailedDescription': 'See Manuscript: 125. Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): An ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health, 15:584 PMID 26073106, 2015.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the Nurturing Families Network Program\n* Singleton birth \\>34 weeks gestation\n* Any race or ethnicity\n* ECHO neighborhood\n* Mothers and their newborns\n\nExclusion Criteria:\n\n* Mothers or newborns with special health care needs\n* Infant with major malformation\n* Small for Gestational Age/low birth weight'}, 'identificationModule': {'nctId': 'NCT02052518', 'acronym': 'ECHO', 'briefTitle': 'Early Childhood Obesity Prevention Program', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'Early Childhood Obesity Prevention Program: Building Better Families and Communities', 'orgStudyIdInfo': {'id': 'HD073966-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced NFN Home Program', 'description': 'Education and Skill set training with materials to implement the behaviors recommended. Using a motivational interviewing framework, intervention participants will receive dietary and activity counseling, develop a Family Wellness Plan and will be linked to community resources.', 'interventionNames': ['Behavioral: Experimental']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nurturing Family Network Home Visitation', 'description': 'Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program', 'interventionNames': ['Behavioral: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'BEHAVIORAL', 'otherNames': ['Enhanced NFN Home Program'], 'description': 'These participants will receive the enhanced intervention including decision support and problem solving skills in addition to the standard of care for the individuals in the Nuturing Family Network Home Visition Program', 'armGroupLabels': ['Enhanced NFN Home Program', 'Nurturing Family Network Home Visitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Michelle M Cloutier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Connecticut Children's Medical Centr"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'When final analysis has been completed and manuscripts have been published, data will be made available upon request to other investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Connecticut', 'class': 'OTHER'}, {'name': 'UConn Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Michelle Cloutier, MD', 'investigatorAffiliation': "Connecticut Children's Medical Center"}}}}