ClinicalTrials.gov
ClinicalTrials.gov Menu

The Psychiatric Rehabilitation Approach to Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00572247
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

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.

Condition or disease Intervention/treatment Phase
Schizophrenic Disorders Behavioral: Psychiatric Rehabilitation Approach to Weight Loss Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.
Study Start Date : January 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Behavioral
Behavioral: Psychiatric Rehabilitation Approach to Weight Loss
The use of psychiatric rehabilitation as a way to lose weight
No Intervention: 2



Primary Outcome Measures :
  1. The reduction of weight and Body Mass Index (BMI) [ Time Frame: Week 12, Week 24, 1 Year from Baseline Visit ]

Secondary Outcome Measures :
  1. Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity [ Time Frame: Baseline, 12 Weeks, 24 weeks, 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572247


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Edna Hamera, PhD, RN, CS University of Kansas Medical Center

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00572247     History of Changes
Other Study ID Numbers: 1R34MH077282-01A1 ( U.S. NIH Grant/Contract )
10575
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders