Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

NCT ID: NCT01368406

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-03-31

Brief 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.

Detailed 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.

Conditions

Schizophrenia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

wellness program

Intervention Type: BEHAVIORAL

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 as usual

patients were on regular visits on psychiatrist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

brazilian wellness program

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Attux

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo A Bressan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Schizophrenia Program (PROESQ)

São Paulo, São Paulo, Brazil

Caps Luiz da Rocha Cerqueira

São Paulo, São Paulo, Brazil

Centro de Atenção Integrada à Saúde Mental (CAISM)

São Paulo, São Paulo, Brazil

Schizophrenia Program of Institute of Psychiatry PROJESQ

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Attux C, Martini LC, Elkis H, Tamai S, Freirias A, Camargo Md, Mateus MD, Mari Jde J, Reis AF, Bressan RA. A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia. BMC Psychiatry. 2013 Feb 18;13:60. doi: 10.1186/1471-244X-13-60.

Reference Type: DERIVED

PMID: 23418863 (View on PubMed)

Other Identifiers

2007/00464-6

Identifier Type: -

Identifier Source: org_study_id