Evaluation of the SickKids Team Obesity Management Program

NCT ID: NCT01515904

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2028-04-30

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

STOMP Clinic

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jill Hamilton

Staff Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jill Hamilton

Role: CONTACT

jill.hamilton@sickkids.ca

416-813-5115 ext. 205115

Other Identifiers

1000025502

Identifier Type: -

Identifier Source: org_study_id