STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- zBMI
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Parenting education sessions
Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits.
Intervention: Parenting education sessions (Behavioral)
Control
Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.
Outcomes
Primary Outcomes
zBMI
Time Frame: 6 months post-intervention
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Secondary Outcomes
- Mental health(6 months post-intervention)
- Eating behaviour and dietary intake(6 months post-intervention)
Investigators
Catherine Birken
Staff Paediatrician
The Hospital for Sick Children