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Clinical Trials/NCT00572247
NCT00572247
Completed
Not Applicable

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

University of Kansas1 site in 1 country133 target enrollmentJanuary 2007
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ConditionsSchizophrenic Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenic Disorders
Sponsor
University of Kansas
Enrollment
133
Locations
1
Primary Endpoint
The reduction of weight and Body Mass Index (BMI)
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The reduction of weight and Body Mass Index (BMI)

Time Frame: Week 12, Week 24, 1 Year from Baseline Visit

Secondary Outcomes

  • Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity(Baseline, 12 Weeks, 24 weeks, 1 year)

Study Sites (1)

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