Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

Federal University of São Paulo

Status: Completed

Conditions: Schizophrenia; Obesity

Treatments: Behavioral: wellness program

Study type: Interventional

Funder types: Other

Identifiers

NCT01368406

2007/00464-6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible patients were between 18 and 65 years of age,
• were on an antipsychotic medication,
• were asymptomatic (PANSS ≤ 60),
• had outpatient status and a DSM-IV diagnosis of schizophrenia,
• schizoaffective disorder or other psychosis, and
• presented some interest on themes of program.

Exclusion criteria

• a history of diabetes mellitus,
• eating disorders (anorexia and bulimia),
• drug or alcohol abuse,
• and an acute psychotic state in need of intensive management.
• There was no use of medication for weight control for the subjects during the intervention and follow-up period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

160 participants in 2 patient groups

wellness program

Experimental group

Description:

12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives

Treatment:

Behavioral: wellness program

treatment as usual

No Intervention group

Description:

patients were on regular visits on psychiatrist