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Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01368406
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Cecilia Attux, Federal University of São Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Obesity Behavioral: wellness program Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Weight From Baseline to Endpoint [ Time Frame: baseline, 3-month ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368406


Locations
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Brazil
Schizophrenia Program (PROESQ)
São Paulo, Brazil, 04044-000
Caps Luiz da Rocha Cerqueira
São Paulo, Brazil
Centro de Atenção Integrada à Saúde Mental (CAISM)
São Paulo, Brazil
Schizophrenia Program of Institute of Psychiatry PROJESQ
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Rodrigo A Bressan, MD, PhD Federal University of São Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cecilia Attux, principal investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01368406    
Other Study ID Numbers: 2007/00464-6
First Posted: June 8, 2011    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: April 2013
Keywords provided by Cecilia Attux, Federal University of São Paulo:
schizophrenia
weight gain
intervention
Additional relevant MeSH terms:
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Weight Gain
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Body Weight Changes
Body Weight