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NCT Number: NCT01515904

Evaluation of the SickKids Team Obesity Management Program

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

Recruiting

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location status: Recruiting

Location contact

Jill Hamilton, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STOMP Clinic

Behavioral

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.

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline

    BMI will be measured at Baseline and 12 months after treatment to evaluate change

  2. Body Mass Index

    Time frame: 12 months

    BMI will be measured at Baseline and 12 months after treatment to evaluate change

Secondary outcomes

  1. Systolic and Diastolic Blood Pressure

    Time frame: Baseline, 12 months

    Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change

  2. Lipid profile

    Time frame: 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

  3. Glycemic control and Insulin resistance

    Time frame: Baseline and 12 months

    Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR

  4. Health and weight-related quality of life

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Hamilton

CONTACT

[email protected]

416-813-5115 ext. 205115

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Evaluation of the SickKids Team Obesity Management Program (STOMP)

Acronym: STOMP

Important dates

Study start
2011
Primary completion
2025
Study completion
2028
First posted
Jan 24, 2012
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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