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Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

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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

May 17, 2011
June 8, 2011
September 12, 2012
May 22, 2013
May 22, 2013
August 2007
March 2009   (Final data collection date for primary outcome measure)
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.
weight [ 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.
Complete list of historical versions of study NCT01368406 on ClinicalTrials.gov Archive Site
Not Provided
  • body mass index [ Time Frame: baseline, 3 months ]
    Body mass index (BMI) was calculated as the weight in kilograms divided by the square of the height in meters.
  • waist circumference [ Time Frame: baseline, 3-month ]
    Waist was considered at the level of the navel.
  • blood pressure [ Time Frame: baseline, 3-month ]
    Blood pressure was assessed by the same investigator
  • blood glucose [ Time Frame: baseline, 3-month ]
  • insulin [ Time Frame: baseline, 3-month ]
  • lipid profile [ Time Frame: baseline, 3-month ]
    total cholesterol, LDL cholesterol, HDL cholesterol, tryglicerides
  • quality of life [ Time Frame: baseline, 3-month ]
    quality of life was assessed using the WHOQoL BREF scale
  • self esteem [ Time Frame: baseline, 3-month ]
    self esteem was assessed using Rosenberg self esteem scale
  • physical activity [ Time Frame: baseline, 3-month ]
    physical activity was assessed using IPAQ short version scale.
  • fibers and fat ingestion [ Time Frame: baseline, 3-month ]
    fibers and fat ingestion was assessed using DINE instrument
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Schizophrenia
  • Obesity
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
  • 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
    Intervention: Behavioral: wellness program
  • No Intervention: treatment as usual
    patients were on regular visits on psychiatrist
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Same as current
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01368406
2007/00464-6
No
Not Provided
Not Provided
Cecilia Attux, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Rodrigo A Bressan, MD, PhD Federal University of São Paulo
Federal University of São Paulo
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP