Evaluation of the SickKids Team Obesity Management Program

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: STOMP Clinic

• Registration Number: NCT01515904
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes of children and adolescents participating in a 'clinical' setting and even fewer reports of outcomes of severely obese pediatric patients. Previously, the investigators evaluated clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children with Central Tumours) and found significant benefit to those attending, including reduction of weight gain (or weight loss), improved psychosocial functioning, and increased care satisfaction. STOMP is a natural extension of this program, incorporating some core elements (e.g., interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a "key worker" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions. Evaluation of the outcomes of this clinic is needed to inform best practice for children and adolescents with severe complex obesity

Detailed Description

The primary objective is to conduct an evaluation of the STOMP clinic as a model of care with a specific focus on: (i) patient outcomes (anthropometric, metabolic, and psychosocial); and (ii) care coordination and care satisfaction.

Patient outcomes will be compared against baseline evaluation data over time, and to a control group of patients not enrolled in the program, but who expressed interest in the program and were unable to attend.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13
• Primary Completion: 2025-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• All patients enrolled in the STOMP program are eligible to participate in the study.
• Control participants must be between 12-18 years of age with a BMI >95th percentile for age.

Exclusion Criteria

• Control participants cannot be enrolled in the STOMP program.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STOMP	STOMP Clinic	12-17 yrs. Patients in the program have severe complex obesity defined as children and youth who have a BMI \>95th %ile for their age and gender in addition to one of the following: at least one significant obesity-related co-morbidity requiring specialty care (e.g. type 2 diabetes), other co-existing chronic illness impacted by obesity (e.g. CNS tumor, post-organ transplant), or a BMI ≥99th percentile for their age and gender

Primary Outcome Measures

Name	Time	Method
Body Mass Index	12 months	BMI will be measured at Baseline and 12 months after treatment to evaluate change

Secondary Outcome Measures

Name	Time	Method
Systolic and Diastolic Blood Pressure	Baseline, 12 months	Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change
Glycemic control and Insulin resistance	Baseline and 12 months	Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR
Lipid profile	Baseline and 12 months	The lipid profile (including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides) will be measured at Baseline and 12 months after treatment to evaluate change
Health and weight-related quality of life	Baseline and 12 months	This outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)

Trial Locations

Locations (1)

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