Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

April 12, 2013 updated by: Cecilia Attux, Federal University of São Paulo

Efficacy of a Non-pharmacological Intervention for Weight Gain Management for Patients With Schizophrenia: Multicentric, Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04044-000
        • Schizophrenia Program (PROESQ)
      • São Paulo, Brazil
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • brazilian wellness program
No Intervention: treatment as usual
patients were on regular visits on psychiatrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Rodrigo A Bressan, MD, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/00464-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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