An observational study in Obesity, sponsored by The Hospital for Sick Children. Recruiting at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by The Hospital for Sick Children · Observational
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
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's planned enrollment of 400 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
Behavioral: 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.
Body Mass Index
BMI will be measured at Baseline and 12 months after treatment to evaluate change
Time frame: Baseline
Body Mass Index
BMI will be measured at Baseline and 12 months after treatment to evaluate change
Time frame: 12 months
Systolic and Diastolic Blood Pressure
Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change
Time frame: Baseline, 12 months
Lipid profile
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
Time frame: Baseline and 12 months
Glycemic control and Insulin resistance
Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR
Time frame: Baseline and 12 months
Health and weight-related quality of life
This outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)
Time frame: Baseline and 12 months
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