STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity

Not Applicable

Completed

• Conditions: Child Obesity
• Interventions: Behavioral: Parenting education sessions

• Registration Number: NCT03219658
• Lead Sponsor: The Hospital for Sick Children

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-17
• Study Start: 2017-10-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenting education sessions	Parenting education sessions	Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits.

Primary Outcome Measures

Name	Time	Method
zBMI	6 months post-intervention	Measure the difference in age and sex-standardized BMI z-score (zBMI)

Secondary Outcome Measures

Name	Time	Method
Mental health	6 months post-intervention	Assess mental health by Strengths and Difficulties Questionnaire
Eating behaviour and dietary intake	6 months post-intervention	Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada