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Completed

NCT Number: NCT00990925

Lifestyle Modification for Weight Loss in Schizophrenia

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects will be between 18 and 65 years of age.
  • Have a BMI of 28 or greater.
  • Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
  • 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

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

Treatment and study plan

Nutritional Lifestyle Modification Group

Behavioral

Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.

Usual Care

Other

Care as usual

Primary outcomes

  1. The primary outcome measure is change in body weight from baseline.

    Time frame: 16 weeks, 6 month follow-up

Secondary outcomes

  1. Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)

    Time frame: 16 weeks, 6 month follow-up

  2. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2009
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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