NCT00564798

Brief 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. A group of subjects who expressed interest in the program but ultimately decided not to participate will be used as a reference group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

3.9 years

First QC Date

November 26, 2007

Last Update Submit

January 27, 2012

Conditions

Obesity

Keywords

protocoladolescentschildrenhealth behaviours/attitudesweight loss/managementprogram evaluation

Study Arms (2)

1

Study Group

2

Control Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Any child NOT referred to the Shapedown program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

ObesityBehavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dina Panagiotopoulos, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 28, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

CA(1)