Lifestyle Modification for Weight Loss in Schizophrenia

November 4, 2015 updated by: Cenk Tek, Yale University
The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

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
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health 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:

  1. Subjects will be between 18 and 65 years of age.
  2. Have a BMI of 28 or greater.
  3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
  4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.

Exclusion Criteria:

  1. A history of dementia or mental retardation.
  2. Not capable of giving informed consent for participation in this study.
  3. Ongoing pregnancy.
  4. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weight Loss Education Group
Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Behavioral: Nutritional Lifestyle Modification Group
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
OTHER: Usual Care
Treatment as usual
Other: Usual Care
Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is change in body weight from baseline.
Time Frame: 16 weeks, 6 month follow-up
16 weeks, 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
Time Frame: 16 weeks, 6 month follow-up
16 weeks, 6 month follow-up
Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)
Time Frame: 16 weeks, 6 month follow-up
16 weeks, 6 month follow-up

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

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

October 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (ESTIMATE)

October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0903004806
  • R01MH080048 (NIH)

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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