Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Cecilia Attux, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01368406
First received: May 17, 2011
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Obesity
Behavioral: wellness program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Non-pharmacological Intervention for Weight Gain Management for Patients With Schizophrenia: Multicentric, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Change in Weight From Baseline to Endpoint [ Time Frame: baseline, 3-month ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: brazilian wellness program
No Intervention: treatment as usual
patients were on regular visits on psychiatrist

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368406

Locations
Brazil
Schizophrenia Program (PROESQ)
São Paulo, Brazil, 04044-000
Schizophrenia Program of Institute of Psychiatry PROJESQ
São Paulo, Brazil
Centro de Atenção Integrada à Saúde Mental (CAISM)
São Paulo, Brazil
Caps Luiz da Rocha Cerqueira
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Rodrigo A Bressan, MD, PhD Federal University of São Paulo
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia Attux, principal investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01368406     History of Changes
Other Study ID Numbers: 2007/00464-6
Study First Received: May 17, 2011
Results First Received: September 12, 2012
Last Updated: April 12, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
schizophrenia
weight gain
intervention

Additional relevant MeSH terms:
Weight Gain
Schizophrenia
Body Weight Changes
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014