Shapedown BC Program Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Obesity

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:

1. 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.
2. To describe changes in BMI in a Natural History group (those choosing not to participate in Shapedown) at 3, 6, 12, 18, 24 months.
3. To perform a process evaluation of the Shapedown program with respect to participation, satisfaction and attrition.
4. 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.
5. 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
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • BC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A prospective evaluation study of the "Shapedown" BC program (Canada) for children aged 6-18 years.

Description

Inclusion Criteria:

All children/families meeting the criteria for the the Shapedown BC program (families and children referred to the Shapedown program).

1. Age 6-18 years inclusive
2. 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.
3. 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.

Exclusion Criteria:

Any child NOT referred to the Shapedown program.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
2; Control Group
1; Study Group

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Dina Panagiotopoulos, MD, University of British Columbia

Publications and helpful links

Helpful Links

• Results

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 26, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 27, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: children; program evaluation; protocoladolescents; health behaviours/attitudes; weight loss/management
• Other Study ID Numbers: H07-00243