STOMP Early Years: A pilot randomized controlled trial of an intensive, family-centred home visiting intervention for young children with severe obesity
Project Lead: Catherine Birken
Timeline: January 2016 – December 2017
Objectives: To determine the feasibility of using the STOMP Early Years intervention (an intensive, pediatric obesity management program designed for 1 to 5 year olds with severe obesity and their families); obtain a reliable estimate of the variance in the primary outcome; and use data from this study to calculate a sample size estimate for a definitive future Randomized Control Trial (RCT).
Research Plan: Using a model that focuses on parents, parents randomized to the intervention group will participate in a modified, group-based version of the Incredible Years program with focus on lifestyle, behavioural and parenting issues and strategies for managing severe obesity in young children. A mental health specialist–dietitian–nurse team will deliver the sessions, which are complemented by four home-based visits by a public health nurse. Families randomized to the control group will be offered the STOMP Early Years program as a delayed treatment following the study period. Children and parents in both groups will complete a comprehensive multidisciplinary assessment at 0- and 6-months follow-up.
Outcomes: This study will provide essential data and experience to plan a definitive, multi-site RCT for managing severe obesity in young children and enable our team to partner with public health professionals (both front-line staff and decision-makers) to manage severe obesity in the community. This trial will offer invaluable experience to evaluate the STOMP Early Years program in other communities.