BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
NCT Number: NCT00564798
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.
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Notify Me6 year–18 year
All sexes
Observational
Vancouver, British Columbia, V6H 3V4, Canada
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All children/families meeting the criteria for the the Shapedown BC program (families and children referred to the Shapedown program).
Exclusion criteria
Any child NOT referred to the Shapedown program.
University of British Columbia
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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