The Psychiatric Rehabilitation Approach to Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00572247
First received: December 11, 2007
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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 Intervention
Schizophrenic Disorders
Behavioral: Psychiatric Rehabilitation Approach to Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • The reduction of weight and Body Mass Index (BMI) [ Time Frame: Week 12, Week 24, 1 Year from Baseline Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity [ Time Frame: Baseline, 12 Weeks, 24 weeks, 1 year ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral
Behavioral: Psychiatric Rehabilitation Approach to Weight Loss
The use of psychiatric rehabilitation as a way to lose weight
No Intervention: 2

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572247

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Edna Hamera, PhD, RN, CS University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00572247     History of Changes
Other Study ID Numbers: 1R34MH077282-01A1, 10575
Study First Received: December 11, 2007
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014