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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368406
• Other study ID #: 2007/00464-6
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: April 12, 2013
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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

Intervention

Behavioral:
• wellness program
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

Locations

Country	Name	City	State
Brazil	Caps Luiz da Rocha Cerqueira	São Paulo
Brazil	Centro de Atenção Integrada à Saúde Mental (CAISM)	São Paulo
Brazil	Schizophrenia Program (PROESQ)	São Paulo
Brazil	Schizophrenia Program of Institute of Psychiatry PROJESQ	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight From Baseline to Endpoint	All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.	baseline, 3-month	No