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Evaluation of the SickKids Team Obesity Management Program

Evaluation of the SickKids Team Obesity Management Program (STOMP)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01515904
Acronym
STOMP
Enrollment
400
Registered
2012-01-24
Start date
2011-04-30
Completion date
2028-04-30
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity management, adolescents, body mass index, treatment outcomes, program evaluation

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.

Interventions

BEHAVIORALSTOMP 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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body Mass IndexBaselineBMI will be measured at Baseline and 12 months after treatment to evaluate change

Secondary

MeasureTime frameDescription
Systolic and Diastolic Blood PressureBaseline, 12 monthsSystolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change
Lipid profileBaseline and 12 monthsThe 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
Glycemic control and Insulin resistanceBaseline and 12 monthsGlycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR
Health and weight-related quality of lifeBaseline and 12 monthsThis outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)

Countries

Canada

Contacts

Primary ContactJill Hamilton
jill.hamilton@sickkids.ca416-813-5115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026