Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-24 @ 11:13 AM
Study NCT ID:
NCT03219658
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parent report focus group', 'timeFrame': '6 months post-intervention', 'description': 'focus group of eligible parents around feasibility and acceptability of the planned intervention'}], 'primaryOutcomes': [{'measure': 'zBMI', 'timeFrame': '6 months post-intervention', 'description': 'Measure the difference in age and sex-standardized BMI z-score (zBMI)'}], 'secondaryOutcomes': [{'measure': 'Mental health', 'timeFrame': '6 months post-intervention', 'description': 'Assess mental health by Strengths and Difficulties Questionnaire'}, {'measure': 'Eating behaviour and dietary intake', 'timeFrame': '6 months post-intervention', 'description': 'Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parenting', 'Home visiting', 'Childhood obesity treatment'], 'conditions': ['Child Obesity']}, 'referencesModule': {'references': [{'pmid': '35085455', 'type': 'DERIVED', 'citation': 'Kinlin LM, Oreskovich SM, Dubrowski R, Ball GDC, Barwick M, Dettmer E, Haines J, Hamilton J, Kim THM, Klaassen M, Luca P, Maguire JL, Moretti ME, Stasiulis E, Toulany A, Birken CS. Managing Obesity in Young Children: A Multiple Methods Study Assessing Feasibility, Acceptability, and Implementation of a Multicomponent, Family-Based Intervention. Child Obes. 2022 Sep;18(6):409-421. doi: 10.1089/chi.2021.0221. Epub 2022 Jan 26.'}]}, 'descriptionModule': {'briefSummary': "This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity.\n\nChildren with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months:\n\nGroup A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP.\n\nGroup B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.\n\nIn addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months:\n\nParenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with obesity and severe obesity (BMI ≥97th percentile) and at least one parent (primary caregiver), and families who are fluent in English (written and oral) will be eligible to participate.\n\nExclusion Criteria:\n\n* Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.'}, 'identificationModule': {'nctId': 'NCT03219658', 'acronym': 'STOMP', 'briefTitle': 'STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity', 'orgStudyIdInfo': {'id': '1000054922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parenting education sessions', 'description': 'Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits.', 'interventionNames': ['Behavioral: Parenting education sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.'}], 'interventions': [{'name': 'Parenting education sessions', 'type': 'BEHAVIORAL', 'description': 'If assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled. During this time, they will also come in for four one-on-one check-ins with the STOMP team. Each check-in will be approximately 1 hour. At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids. The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study. The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family.', 'armGroupLabels': ['Parenting education sessions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Paediatrician', 'investigatorFullName': 'Catherine Birken', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}