Clinical trial NCT01368406: Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
Official title: Efficacy of a Non-pharmacological Intervention for Weight Gain Management for Patients With Schizophrenia: Multicentric, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Obesity
Keywords: schizophrenia
weight gain
intervention
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-06-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Weight From Baseline to Endpoint
timeFrame: baseline, 3-month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Schizophrenia Program (PROESQ)
city: São Paulo
country: Brazil
facility: Caps Luiz da Rocha Cerqueira
city: São Paulo
country: Brazil
facility: Centro de Atenção Integrada à Saúde Mental (CAISM)
city: São Paulo
country: Brazil
facility: Schizophrenia Program of Institute of Psychiatry PROJESQ
Study officials:
affiliation: Federal University of São Paulo
name: Rodrigo A Bressan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.