Evaluation of the SickKids Team Obesity Management Program

NCT01515904 | Recruiting

• 1 other identifier: 1000025502
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

obesity management; adolescents; body mass index; treatment outcomes; program evaluation

Outcome Measures

Primary Outcomes (2)

• Body Mass Index

  BMI will be measured at Baseline and 12 months after treatment to evaluate change

  Baseline

• Body Mass Index

  BMI will be measured at Baseline and 12 months after treatment to evaluate change

  12 months

Secondary Outcomes (4)

• Systolic and Diastolic Blood Pressure

  Baseline, 12 months

• Lipid profile

  Baseline and 12 months

• Glycemic control and Insulin resistance

  Baseline and 12 months

• Health and weight-related quality of life

  Baseline and 12 months

Study Arms (2)

Control

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

STOMP

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

Interventions

STOMP Clinic BEHAVIORAL

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.

STOMP

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Control participants cannot be enrolled in the STOMP program.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jill Hamilton, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Hamilton

CONTACT

416-813-5115; jill.hamilton@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Endocrinologist

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 24, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

CA (1)