Recruiting

Obesity Management

Sponsor:

The Hospital for Sick Children

Code:

NCT01515904

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

STOMP Clinic

Study Details

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

Conditions

Obesity

Study ID

NCT01515904

Start date

Apr, 2011

Status verified date

Sep, 2022

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Approximately 50% of attendees choose not to book into the STOMP program, for reasons including difficulty attending the frequent appointments due to distance or inability to leave work early. This population will serve as the control group for the evaluation. Control participants will be recruited from the community through posters in the hospital

STOMP

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

Interventions

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.

Primary outcome measure

  • Body Mass Index [ Time Frame: Baseline ]
  • Body Mass Index [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jill Hamilton

416-813-5115jill.hamilton@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5V1X8

Principal Investigator:

Jill Hamilton, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Sep 13, 2022

Last verified

Sep, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2022-09-13.