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

NCT03219658 | Completed

• 1 other identifier: 1000054922
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Child Obesity

Keywords

Parenting; Home visiting; Childhood obesity treatment

Outcome Measures

Primary Outcomes (1)

• zBMI

  Measure the difference in age and sex-standardized BMI z-score (zBMI)

  6 months post-intervention

Secondary Outcomes (2)

• Mental health

  6 months post-intervention

• Eating behaviour and dietary intake

  6 months post-intervention

Other Outcomes (1)

• Parent report focus group

  6 months post-intervention

Study Arms (2)

Parenting education sessions

EXPERIMENTAL

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

Behavioral: Parenting education sessions

Control

NO INTERVENTION

Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.

Interventions

Parenting education sessions BEHAVIORAL

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.

Parenting education sessions

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 35085455 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Paediatrician

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 17, 2017
• Study Start: October 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)