NCT00572247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

December 11, 2007

Last Update Submit

March 5, 2012

Conditions

Schizophrenic Disorders

Outcome Measures

Primary Outcomes (1)

  • The reduction of weight and Body Mass Index (BMI)

    Week 12, Week 24, 1 Year from Baseline Visit

Secondary Outcomes (1)

  • Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity

    Baseline, 12 Weeks, 24 weeks, 1 year

Study Arms (2)

1

EXPERIMENTAL

Behavioral

Behavioral: Psychiatric Rehabilitation Approach to Weight Loss

2

NO INTERVENTION

Interventions

Psychiatric Rehabilitation Approach to Weight LossBEHAVIORAL

The use of psychiatric rehabilitation as a way to lose weight

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Edna Hamera, PhD, RN, CS

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

December 1, 2010

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(1)