ObesitySTOMPNCT01515904
Evaluation of the SickKids Team Obesity Management Program
An observational study of Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- STOMP Clinic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Control participants cannot be enrolled in the STOMP program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5V1X8
Jill Hamilton, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- STOMP Clinic
- Keywords
- obesity management, adolescents, body mass index, treatment outcomes, program evaluation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOMP ClinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: STOMP Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI will be measured at Baseline and 12 months after treatment to evaluate change
Measured: Baseline
Body Mass Index
BMI will be measured at Baseline and 12 months after treatment to evaluate change
Measured: 12 months
Secondary outcomes (4)
Systolic and Diastolic Blood Pressure
Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2025 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515904
- Sponsor's protocol ID
- 1000025502
- Acronym
- STOMP
- Status last verified
- Sep 2022
- First submitted
- 18 Jan 2012
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SickKids Team Obesity Management Program (STOMP)
- ClinicalTrials.gov ID
- NCT01515904
- Acronym / sponsor ID
- STOMP / 1000025502
- Conditions
- Obesity
- Keywords
- obesity management, adolescents, body mass index, treatment outcomes, program evaluation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: STOMP Clinic12-17 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Control participants cannot be enrolled in the STOMP program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOMP ClinicA 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. | Behavioural | STOMP |
Primary outcome
Body Mass Index
Time frame: Baseline
BMI will be measured at Baseline and 12 months after treatment to evaluate change
Body Mass Index
Time frame: 12 months
BMI will be measured at Baseline and 12 months after treatment to evaluate change
4 secondary outcomes
Systolic and Diastolic Blood Pressure
Time frame: Baseline, 12 months
Lipid profile
Time frame: Baseline and 12 months
Glycemic control and Insulin resistance
Time frame: Baseline and 12 months
Health and weight-related quality of life
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill Hamilton, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Hamilton (416-813-5115 ext. 205115, jill.hamilton@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.