Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
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Purpose
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 | Intervention |
|---|---|
|
Schizophrenia Obesity |
Behavioral: wellness program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Change in Weight From Baseline to Endpoint [ Time Frame: baseline, 3-month ] [ Designated as safety issue: No ]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.
| Enrollment: | 160 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Brazil | |
| Schizophrenia Program (PROESQ) | |
| São Paulo, Brazil, 04044-000 | |
| Schizophrenia Program of Institute of Psychiatry PROJESQ | |
| São Paulo, Brazil | |
| Centro de Atenção Integrada à Saúde Mental (CAISM) | |
| São Paulo, Brazil | |
| Caps Luiz da Rocha Cerqueira | |
| São Paulo, Brazil | |
| Principal Investigator: | Rodrigo A Bressan, MD, PhD | Federal University of São Paulo |
More Information
No publications provided by Federal University of São Paulo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cecilia Attux, principal investigator, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01368406 History of Changes |
| Other Study ID Numbers: | 2007/00464-6 |
| Study First Received: | May 17, 2011 |
| Results First Received: | September 12, 2012 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
schizophrenia weight gain intervention |
Additional relevant MeSH terms:
|
Obesity Schizophrenia Weight Gain Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders Body Weight Changes |
ClinicalTrials.gov processed this record on May 23, 2013