The Psychiatric Rehabilitation Approach to Weight Loss

March 5, 2012 updated by: University of Kansas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Edna Hamera, PhD, RN, CS, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH077282-01A1 (U.S. NIH Grant/Contract)
  • 10575 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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