NCT01515904 Evaluation of the SickKids Team Obesity Management Program
| NCT ID | NCT01515904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2011-04 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2011-04 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Jill Hamilton, MD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT01515904 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01515904 currently recruiting?
Yes, NCT01515904 is actively recruiting participants. Contact the research team at jill.hamilton@sickkids.ca for enrollment information.
Where is the NCT01515904 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT01515904 clinical trial?
NCT01515904 is sponsored by The Hospital for Sick Children. The principal investigator is Jill Hamilton, MD at The Hospital for Sick Children. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.