Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
Primary Purpose
Schizophrenia, Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
wellness program
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring schizophrenia, weight gain, intervention
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.
Sites / Locations
- Schizophrenia Program (PROESQ)
- Caps Luiz da Rocha Cerqueira
- Centro de Atenção Integrada à Saúde Mental (CAISM)
- Schizophrenia Program of Institute of Psychiatry PROJESQ
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
wellness program
treatment as usual
Arm Description
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
patients were on regular visits on psychiatrist
Outcomes
Primary Outcome Measures
Change in Weight From Baseline to Endpoint
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01368406
First Posted
May 17, 2011
Last Updated
April 12, 2013
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01368406
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Obesity
Keywords
schizophrenia, weight gain, intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
wellness program
Arm Type
Experimental
Arm Description
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
Arm Title
treatment as usual
Arm Type
No Intervention
Arm Description
patients were on regular visits on psychiatrist
Intervention Type
Behavioral
Intervention Name(s)
wellness program
Other Intervention Name(s)
brazilian wellness program
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Weight From Baseline to Endpoint
Description
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.
Time Frame
baseline, 3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo A Bressan, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schizophrenia Program (PROESQ)
City
São Paulo
ZIP/Postal Code
04044-000
Country
Brazil
Facility Name
Caps Luiz da Rocha Cerqueira
City
São Paulo
Country
Brazil
Facility Name
Centro de Atenção Integrada à Saúde Mental (CAISM)
City
São Paulo
Country
Brazil
Facility Name
Schizophrenia Program of Institute of Psychiatry PROJESQ
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23418863
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.
Results Reference
derived
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Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
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