Lifestyle Modification for Weight Loss in Schizophrenia

Yale University

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder; Obesity

Treatments: Other: Usual Care; Behavioral: Nutritional Lifestyle Modification Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00990925

0903004806

R01MH080048 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

149 participants in 2 patient groups

Weight Loss Education Group

Experimental group

Description:

Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.

Treatment:

Behavioral: Nutritional Lifestyle Modification Group

Usual Care

Other group

Description:

Treatment as usual

Treatment:

Other: Usual Care