Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
Efficacy of a Non-pharmacological Intervention for Weight Gain Management for Patients With Schizophrenia: Multicentric, Randomized Clinical Trial
1 other identifier
interventional
160
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Aug 2007
Shorter than P25 for not_applicable schizophrenia
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedResults Posted
Study results publicly available
May 22, 2013
CompletedMay 22, 2013
April 1, 2013
1.6 years
May 17, 2011
September 12, 2012
April 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline, 3-month
Study Arms (2)
wellness program
EXPERIMENTAL12-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
treatment as usual
NO INTERVENTIONpatients were on regular visits on psychiatrist
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Schizophrenia Program (PROESQ)
São Paulo, São Paulo, 04044-000, Brazil
Caps Luiz da Rocha Cerqueira
São Paulo, São Paulo, Brazil
Centro de Atenção Integrada à Saúde Mental (CAISM)
São Paulo, São Paulo, Brazil
Schizophrenia Program of Institute of Psychiatry PROJESQ
São Paulo, São Paulo, Brazil
Related Publications (1)
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.
PMID: 23418863DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
short duration of the intervention (12 weeks) and duration of follow up. This lifestyle intervention was previously conducted in all sites that participated of this study.
Results Point of Contact
- Title
- Cecilia Attux
- Organization
- Programa de Esquizofrenia PROESQ UNIFESP
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo A Bressan, MD, PhD
Federal University of São Paulo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 17, 2011
First Posted
June 8, 2011
Study Start
August 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 22, 2013
Results First Posted
May 22, 2013
Record last verified: 2013-04