Evaluation of the SickKids Team Obesity Management Program (STOMP)

This study is currently recruiting participants.
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Jill Hamilton, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01515904
First received: January 18, 2012
Last updated: August 14, 2013
Last verified: August 2013

January 18, 2012
August 14, 2013
April 2011
April 2016   (final data collection date for primary outcome measure)
  • Body Mass Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    BMI will be measured at Baseline and 12 months after treatment to evaluate change
  • Body Mass Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    BMI will be measured at Baseline and 12 months after treatment to evaluate change
Same as current
Complete list of historical versions of study NCT01515904 on ClinicalTrials.gov Archive Site
  • Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change
  • Lipid profile [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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
  • Glycemic control and Insulin resistance [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR
  • Health and weight-related quality of life [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    This outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)
Same as current
Not Provided
Not Provided
 
Evaluation of the SickKids Team Obesity Management Program
Evaluation of the SickKids Team Obesity Management Program (STOMP)

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

STOMP Group: 12-17 years of age. Patients in the program have severe complex obesity which is defined as as children and youth who have a BMI >95th percentile for their age and gender in addition to any one of the following: at least one significant obesity-related co-morbidity requiring specialty care (e.g. type 2 diabetes, hypertension), 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. In addition, control participants will be recruited from the community through posters posted in the hospital.

Obesity
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.
  • Control
  • STOMP
    Intervention: Behavioral: STOMP Clinic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
April 2016
April 2016   (final data collection date for primary outcome measure)

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.

Both
12 Years to 18 Years
No
Contact: Munaza Jamil 416-813-7654 ext 328363 munaza.jamil@sickkids.ca
Canada
 
NCT01515904
1000025502
No
Jill Hamilton, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Jill Hamilton, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP