Shapedown BC Program Evaluation
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|ClinicalTrials.gov Identifier: NCT00564798|
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : January 31, 2012
|Condition or disease|
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)
- 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 Type :||Observational|
|Actual Enrollment :||119 participants|
|Observational Model:||Case Control|
|Official Title:||Shapedown BC Program Evaluation|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564798
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Dina Panagiotopoulos, MD||University of British Columbia|