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Shapedown BC Program Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00564798
First received: November 26, 2007
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Shapedown BC Program Evaluation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Enrollment: 119
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Study Group
2
Control 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:

  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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564798

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dina Panagiotopoulos, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00564798     History of Changes
Other Study ID Numbers: H07-00243
Study First Received: November 26, 2007
Last Updated: January 27, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
protocoladolescents
children
health behaviours/attitudes
weight loss/management
program evaluation

ClinicalTrials.gov processed this record on November 25, 2014