Chrysalis Day Program Body Mass Index Study | NCT00202215

Studies
Chrysalis Day Program Body Mass Index Study

NCT00202215

Sponsor

Queen's University

Status

Completed

Last Update Posted

Oct 16, 2007Estimated

Enrollment

106Actual

Phase

Not Applicable

Conditions

Borderline Personality Disorder
Eating Disorders

Interventions

Chrysalis Day Program

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2007

Last Update Posted Date

Oct 16, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Queen's UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)

Detailed Description

As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients.

At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician.

When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values.

The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Name	Type	Description	Arm Group Labels	Other Names
Chrysalis Day Program	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Mass Index at time of enrolling in programme and at leaving		at entry and upon leaving the program

Secondary Outcomes

Measure	Description	Time Frame
patient demographics relationship to outcome		upon entry and exit from the program
programme changes and relation to outcome		from start to the end of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clients of the Chrysalis Program

Exclusion Criteria:

clients of the Chrysalis Program who do not consent to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen H McNevin, MD	Queens University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Providence Care Centre Mental Health Services		Kingston	Ontario	K7L 4X3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder
D001068	Feeding and Eating Disorders

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided