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

Child Obesity Clinical Trial

— STOMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219658
• Other study ID #: 1000054922
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Obesity, Morbid
• Pediatric Obesity

Intervention

Behavioral:
• Parenting education sessions
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent report focus group	focus group of eligible parents around feasibility and acceptability of the planned intervention	6 months post-intervention
Primary	zBMI	Measure the difference in age and sex-standardized BMI z-score (zBMI)	6 months post-intervention
Secondary	Mental health	Assess mental health by Strengths and Difficulties Questionnaire	6 months post-intervention
Secondary	Eating behaviour and dietary intake	Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)	6 months post-intervention