Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

Obesity Clinical Trial

Official title: Efficacy of a Non-pharmacological Intervention for Weight Gain Management for Patients With Schizophrenia: Multicentric, Randomized Clinical Trial

Status Completed

Clinical Trial Summary

The aims of this study were to evaluate the efficacy of an intervention for weight gain management for patients from schizophrenia spectrum compared to treatment as usual (TAU), and to evaluate the effects of this program on metabolic profile, symptoms and quality of life.

Clinical Trial Description

The study took place on four institutions: Schizophrenia Program (PROESQ- Universidade Federal de São Paulo), Schizophrenia Program of Institute of Psychiatry PROJESQ (Universidade de São Paulo), CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa de Misericórdia de São Paulo, and CAPS Luiz da Rocha Cerqueira, all in the city of São Paulo. Participants were randomly assigned to an intervention group or a standard care group using table of randomization from web site www.randomization.com. The patients' weights were recorded monthly. All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes. Waist was considered at the level of the navel. Measures were collected by the same investigator in all assessments. Body mass index (BMI) was calculated as the weight in kilograms divided by the square of the height in meters. The investigators recorded sociodemographic data, clinical data and physical exam (weight, height, BMI, waist circumference and blood pressure). Patients were diagnosed as having schizophrenia by the SCID-P (REF). Severity of the disease was assessed using PANSS, Calgary Depression Scale, CGI-S and CGI-I. GAF, ILSS-BR, and he following self-rated scales: WHOQoL-BREF, Rosenberg self-esteem scale, IPAQ, DINE and Fagerstrom were used to evaluate functionality (GAF), independent living skills (ILSS-BR), quality of life (WHOQoL-BREF), self esteem (Rosenberg self-esteem scale), physical activity (IPAQ- short version), fat and fibers ingestion (DINE), and smoking (Fagerstrom). Raters were kept blind for patient's treatment condition. Fasting glucose, total cholesterol, HDL, LDL, triglycerides, insulin, and HOMA-IR index were assessed at baseline, and 3 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Schizophrenia
• Weight Gain

• NCT number: NCT01368406
• Study type: Interventional
• Source: Federal University of São Paulo
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Completion date: March 2009