The Psychiatric Rehabilitation Approach to Weight Loss

Schizophrenic Disorders Clinical Trial

Official title:

The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572247
• Other study ID #: 1R34MH077282-01A1
• Secondary ID: 10575
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: March 5, 2012
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenic Disorders

Intervention

Behavioral:
• Psychiatric Rehabilitation Approach to Weight Loss
The use of psychiatric rehabilitation as a way to lose weight

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction of weight and Body Mass Index (BMI)		Week 12, Week 24, 1 Year from Baseline Visit	No
Secondary	Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity		Baseline, 12 Weeks, 24 weeks, 1 year	No