ObesityNCT00564798
Shapedown BC Program Evaluation
An observational study of Obesity, run by University of British Columbia at 1 site in Canada.
Trial summary
Shapedown BC is being implemented at a single centre (BC's Children's Hospital). We will use the data routinely collected by the Shapedown program and evaluate the effect of the program and whether any changes are sustained for up to 2 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obesity
- How many people
- 119 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A prospective evaluation study of the "Shapedown" BC program (Canada) for children aged 6-18 years.
Who may be able to join
- All children/families meeting the criteria for the the Shapedown BC program (families and children referred to the Shapedown program).
- Age 6-18 years inclusive
- Body mass index greater than or equal to the 95th percentile standardized for age and sex or Body mass index greater than or equal to 85th percentile but less than 95th percentile with co-morbidities such as hypertension, IGT, or type 2 diabetes, PCOS, dyslipidemia, and NASH.
- Parents or primary care givers/guardians willing to attend the two intake sessions with the expectation that they will be required to participate in the entire program.
Who cannot join
- Any child NOT referred to the Shapedown program.
Trial locations and contacts
1 site in 1 country.
About this study
Shapedown BC is being implemented at a single centre (BC's Children's Hospital). We will use the data routinely collected by the Shapedown program and evaluate the effect of the program and whether any changes are sustained for up to 2 years. A group of subjects who expressed interest in the program but ultimately decided not to participate will be used as a reference group.
Read the detailed description
With the increase in obesity among children and adolescents in Canada, there is a commensurate rise in the incidence of type 2 diabetes (T2D), and the age at which it is appearing is getting lower. Reversing obesity is a critical primary intervention for the prevention of the development of T2D in children/adolescents. Achieving long-term weight change has proven to be very difficult, particularly for children. The Shapedown program is a well-structured but resource-intensive program for weight management in children and adolescents. Like many obesity intervention programs, its efficacy has not been evaluated. If it is shown to have long term impact on obesity, and thus reduce the incidence of T2D and the demand on the health care system for other co-morbidities of obesity, the costs are likely warranted. However, if Shapedown is not efficacious at reversing obesity or the physiologic markers for its complications, the high demand on health care resources may not be warranted.
Hypothesis The Shapedown treatment group will have a reduction in Body Mass Index (BMI) of 0.75 kg/m2 at 3 months compared to baseline evaluation and this reduction will be sustained for 12 and 24 months.
Primary Objective To determine whether Shapedown BC is efficacious at reducing BMI by 0.75 kg/m2 at the completion of the 10 week treatment program (3 month assessment)
Secondary Objectives:
- To determine whether the reduction in BMI achieved at 3 months can be sustained at 6, 12, 18 and 24 months after the Shapedown intervention.
- To describe changes in BMI in a Natural History group (those choosing not to participate in Shapedown) at 3, 6, 12, 18, 24 months.
- To perform a process evaluation of the Shapedown program with respect to participation, satisfaction and attrition.
- To perform an exploratory analysis of the psychological assessments of the Shapedown treatment group at the end of the program, 3 and 12 months post-intervention compared to baseline.
- To evaluate changes in physical fitness in the Shapedown treatment group at the end of Shapedown program, 3 and 12 months post intervention compared to baseline.
Research Design The program will be evaluated by following a prospective cohort of those treated through the Shapedown program, with the additional component of a "Natural History",non-participant group.
Relevance Obesity is the primary risk factor for the development of T2D.
Outcome/Impact This study provides critical data on the efficacy of Shapedown as a weight management program as well as its effect on changing insulin resistance in children. We will also gain important epidemiological information on the co-morbidities present in obese children. We will also gain knowledge on the reasons certain families decline to participate, barriers to treatment, as well as the natural history of weight gain in the non-participant group.
- Conditions
- Obesity
- Keywords
- protocoladolescents, children, health behaviours/attitudes, weight loss/management, program evaluation
- Medical subject headings
- Obesity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Study Group | |
| 2 | Control Group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
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 University of British ColumbiaThe 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina Panagiotopoulos, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564798
- Sponsor's protocol ID
- H07-00243
- Status last verified
- Jan 2012
- First submitted
- 26 Nov 2007
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shapedown BC Program Evaluation
- ClinicalTrials.gov ID
- NCT00564798
- Acronym / sponsor ID
- H07-00243
- Conditions
- Obesity
- Keywords
- protocoladolescents, children, health behaviours/attitudes, weight loss/management, program evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Nov 2007 (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.
Shapedown BC is being implemented at a single centre (BC's Children's Hospital). We will use the data routinely collected by the Shapedown program and evaluate the effect of the program and whether any changes are sustained for up to 2 years. A group of subjects who expressed interest in the program but ultimately decided not to participate will be used as a reference group.
Detailed description
With the increase in obesity among children and adolescents in Canada, there is a commensurate rise in the incidence of type 2 diabetes (T2D), and the age at which it is appearing is getting lower. Reversing obesity is a critical primary intervention for the prevention of the development of T2D in children/adolescents. Achieving long-term weight change has proven to be very difficult, particularly for children. The Shapedown program is a well-structured but resource-intensive program for weight management in children and adolescents. Like many obesity intervention programs, its efficacy has not been evaluated. If it is shown to have long term impact on obesity, and thus reduce the incidence of T2D and the demand on the health care system for other co-morbidities of obesity, the costs are likely warranted. However, if Shapedown is not efficacious at reversing obesity or the physiologic markers for its complications, the high demand on health care resources may not be warranted.
Hypothesis The Shapedown treatment group will have a reduction in Body Mass Index (BMI) of 0.75 kg/m2 at 3 months compared to baseline evaluation and this reduction will be sustained for 12 and 24 months.
Primary Objective To determine whether Shapedown BC is efficacious at reducing BMI by 0.75 kg/m2 at the completion of the 10 week treatment program (3 month assessment)
Secondary Objectives:
- To determine whether the reduction in BMI achieved at 3 months can be sustained at 6, 12, 18 and 24 months after the Shapedown intervention.
- To describe changes in BMI in a Natural History group (those choosing not to participate in Shapedown) at 3, 6, 12, 18, 24 months.
- To perform a process evaluation of the Shapedown program with respect to participation, satisfaction and attrition.
- To perform an exploratory analysis of the psychological assessments of the Shapedown treatment group at the end of the program, 3 and 12 months post-intervention compared to baseline.
- To evaluate changes in physical fitness in the Shapedown treatment group at the end of Shapedown program, 3 and 12 months post intervention compared to baseline.
Research Design The program will be evaluated by following a prospective cohort of those treated through the Shapedown program, with the additional component of a "Natural History",non-participant group.
Relevance Obesity is the primary risk factor for the development of T2D.
Outcome/Impact This study provides critical data on the efficacy of Shapedown as a weight management program as well as its effect on changing insulin resistance in children. We will also gain important epidemiological information on the co-morbidities present in obese children. We will also gain knowledge on the reasons certain families decline to participate, barriers to treatment, as well as the natural history of weight gain in the non-participant group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Study Group |
| 2 | – | –Control Group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A prospective evaluation study of the "Shapedown" BC program (Canada) for children aged 6-18 years.
Key inclusion criteria (4 listed)
- All children/families meeting the criteria for the the Shapedown BC program (families and children referred to the Shapedown program).
- Age 6-18 years inclusive
- Body mass index greater than or equal to the 95th percentile standardized for age and sex or Body mass index greater than or equal to 85th percentile but less than 95th percentile with co-morbidities such as hypertension, IGT, or type 2 diabetes, PCOS, dyslipidemia, and NASH.
- Parents or primary care givers/guardians willing to attend the two intake sessions with the expectation that they will be required to participate in the entire program.
Key exclusion criteria (1 listed)
- Any child NOT referred to the Shapedown program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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. This study is not recruiting at the moment.
Dina Panagiotopoulos, MD principal investigator
University of British Columbia
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 University of British Columbia 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 4 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: finished, as of the sponsor's last update on 31 Jan 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 31 Jan 2012.