Evaluation of the SickKids Team Obesity Management Program

Obesity Clinical Trial

— STOMP  

Official title:

Evaluation of the SickKids Team Obesity Management Program (STOMP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01515904
• Other study ID #: 1000025502
• Status: Recruiting
• Start date: April 2011
• Est. completion date: April 2028

Study information

• Verified date: September 2022
• Source: The Hospital for Sick Children
• Contact: Jill Hamilton
• Phone: 416-813-5115
• Email: jill.hamilton[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• STOMP Clinic
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. The core elements include an 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.

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
Primary	Body Mass Index	BMI will be measured at Baseline and 12 months after treatment to evaluate change	Baseline
Primary	Body Mass Index	BMI will be measured at Baseline and 12 months after treatment to evaluate change	12 months
Secondary	Systolic and Diastolic Blood Pressure	Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change	Baseline, 12 months
Secondary	Lipid profile	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	Baseline and 12 months
Secondary	Glycemic control and Insulin resistance	Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR	Baseline and 12 months
Secondary	Health and weight-related quality of life	This outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)	Baseline and 12 months