Clinical trial NCT01515904: Evaluation of the SickKids Team Obesity Management Program
Official title: Evaluation of the SickKids Team Obesity Management Program (STOMP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: obesity management
adolescents
body mass index
treatment outcomes
program evaluation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STOMP Group: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 Control: Approximately 50% of attendees choose not to book into the 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.

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.

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.

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index
timeFrame: 12 months
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 12 months
measure: Lipid profile
timeFrame: Baseline and 12 months
measure: Glycemic control and Insulin resistance
timeFrame: Baseline and 12 months
measure: Health and weight-related quality of life
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jill Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References: