Evaluation of the SickKids Team Obesity Management Program (STOMP)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention
Obesity
Behavioral: STOMP Clinic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the SickKids Team Obesity Management Program (STOMP)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 110
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
STOMP 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.

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515904

Contacts
Contact: Munaza Jamil 416-813-7654 ext 328363 munaza.jamil@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Jill Hamilton, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jill Hamilton, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Jill Hamilton, Staff Endocrinologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01515904     History of Changes
Other Study ID Numbers: 1000025502
Study First Received: January 18, 2012
Last Updated: August 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
obesity management
adolescents
body mass index
treatment outcomes
program evaluation

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014