- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03219658
STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity (STOMP)
STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
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.
Children 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:
Group 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.
Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.
In 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:
Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Parenting education sessions
Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits.
|
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.
|
Ingen indgriben: Control
Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
zBMI
Tidsramme: 6 months post-intervention
|
Measure the difference in age and sex-standardized BMI z-score (zBMI)
|
6 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mental health
Tidsramme: 6 months post-intervention
|
Assess mental health by Strengths and Difficulties Questionnaire
|
6 months post-intervention
|
Eating behaviour and dietary intake
Tidsramme: 6 months post-intervention
|
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
|
6 months post-intervention
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Parent report focus group
Tidsramme: 6 months post-intervention
|
focus group of eligible parents around feasibility and acceptability of the planned intervention
|
6 months post-intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1000054922
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Børns fedme
-
MedDay Pharmaceuticals SAEurofins OptimedAfsluttetSunde frivillige | Nedsat leverfunktion af moderat Child Pugh-kategoriFrankrig, Ungarn
-
RenJi HospitalAfsluttetBlodpladeantal/miltdiameterforhold | Child-Pugh klassificeringKina
-
Stanford UniversityNational Cancer Institute (NCI)AfsluttetTilbagevendende hepatocellulært karcinom | Child-Pugh klasse A | Child-Pugh klasse BForenede Stater, Japan
-
Ohio State University Comprehensive Cancer CenterVarian Medical SystemsAfsluttetChild-Pugh klasse A | Stadium IIIA Hepatocellulært karcinom | Stadium IIIB hepatocellulært karcinom | Stadium IIIC hepatocellulært karcinom | Stadium IVA Hepatocellulært karcinom | Stadium IVB Hepatocellulært karcinom | Child-Pugh klasse BForenede Stater
-
Centre Hospitalier Universitaire DijonAfsluttetChild-Pugh A Hepatocellulært karcinomFrankrig
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCAktiv, ikke rekrutterendeAvanceret hepatocellulært karcinom hos voksne | Child-Pugh klasse A | Trin III hepatocellulært karcinom | Stadium IIIA Hepatocellulært karcinom | Stadium IIIB hepatocellulært karcinom | Stadium IIIC hepatocellulært karcinom | Trin IV hepatocellulært karcinom | Stadium IVA Hepatocellulært karcinom | Stadium...Forenede Stater
-
AstraZenecaAfsluttetMavekræft | Avancerede solide maligniteter | Solid tumor | Child-Pugh A til B7 avanceret hepatocellulært karcinom | EGFR og/eller ROS Mutant NSCLC | LungemetastasekarcinomKorea, Republikken
Kliniske forsøg med Parenting education sessions
-
Istituti Clinici Scientifici Maugeri SpATrukket tilbage
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Afsluttet
-
NYU Langone HealthTrukket tilbage
-
University of ManitobaUniversity of Calgary; Tactica Interactive; Centre for Healthcare Innovation og andre samarbejdspartnereUkendt
-
Virginia Commonwealth UniversityNational Institute on Minority Health and Health Disparities (NIMHD)AfsluttetHIV-infektioner | StofbrugForenede Stater
-
Rehabilitation Centre for Children, CanadaAfsluttetAutismespektrumforstyrrelse (ASD) | UdviklingsforstyrrelseCanada
-
University of NottinghamNational Institute for Health Research, United Kingdom; Institute of Mental...UkendtAttention Deficit Hyperactivity Disorder (ADHD)
-
Wayne State UniversityAfsluttetForstyrrende adfærdsforstyrrelserForenede Stater
-
University Hospital, Strasbourg, FranceAfsluttet
-
China Medical University HospitalAfsluttet