Clinical trial NCT03219658: STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
Official title: STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Keywords: Parenting
Home visiting
Childhood obesity treatment
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: zBMI
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Mental health
timeFrame: 6 months post-intervention
measure: Eating behaviour and dietary intake
timeFrame: 6 months post-intervention
Other outcomes:
measure: Parent report focus group
timeFrame: 6 months post-intervention
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
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.