The Psychiatric Rehabilitation Approach to Weight Loss | NCT00572247

Studies
The Psychiatric Rehabilitation Approach to Weight Loss

NCT00572247

Sponsor

University of Kansas

Status

Completed

Last Update Posted

Mar 7, 2012Estimated

Enrollment

133Actual

Phase

Not Applicable

Conditions

Schizophrenic Disorders

Interventions

Psychiatric Rehabilitation Approach to Weight Loss

Countries

United States

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

ID	Type	Description	Link
10575

Status Module

Record Verification Date

Mar 2012

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

Jan 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 11, 2007

First Posted Date

Dec 13, 2007Estimated

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

Mar 5, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.

Detailed Description

The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.

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

133Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Behavioral	Behavioral: Psychiatric Rehabilitation Approach to Weight Loss
2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychiatric Rehabilitation Approach to Weight Loss	Behavioral	The use of psychiatric rehabilitation as a way to lose weight	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The reduction of weight and Body Mass Index (BMI)		Week 12, Week 24, 1 Year from Baseline Visit

Secondary Outcomes

Measure	Description	Time Frame
Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity		Baseline, 12 Weeks, 24 weeks, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of serious mental illness,
Age 18 - 65
BMI > 25
Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months).

Exclusion Criteria:

Current or history of eating disorder
Pregnant or breast feeding
Uncontrolled HTN
Severe coronary artery disease
Severe valvular disease
Uncontrolled diabetes
Sustained arrhythmia
Insulin using severe physical limitations
Severe Lung Disorders
Diagnosis of MR or dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edna Hamera, PhD, RN, CS	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided