Schizophrenia, Obesity
Conditions
Keywords
schizophrenia, weight gain, intervention
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.
Interventions
BEHAVIORALwellness 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
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight From Baseline to Endpoint | 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. |
Countries
Brazil
Participant flow
Recruitment details
Patients were drawn from: a) the Schizophrenia Program- Universidade Federal de São Paulo); b) the Schizophrenia Program of Institute of Psychiatry PROJESQ (Universidade de São Paulo); c) the CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa de São Paulo; and d) the Community Psychosocial Center Luiz da Rocha Cerqueira.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 81 |
| Treatment as Usual treatment as usual received by the patients | 79 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 4 |
| Overall Study | relapse of the disease | 3 | 2 |
| Overall Study | started working | 2 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Treatment as Usual | Wellness Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 81 Participants | 160 Participants |
| Age Continuous | 38.3 years STANDARD_DEVIATION 10.7 | 36.2 years STANDARD_DEVIATION 9.9 | 37.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Brazil | 79 participants | 81 participants | 160 participants |
| Sex: Female, Male Female | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Male | 46 Participants | 50 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
Primary
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.
Time frame: baseline, 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Program | Change in Weight From Baseline to Endpoint | 0.48 kg | — |
| Treatment as Usual | Change in Weight From Baseline to Endpoint | 0.48 kg | 95% Confidence Interval 17.8 |
p-value: 0.05595% CI: [-0.65, 1.13]t-test, 2 sided
p-value: 0.05595% CI: [0.13, 0.83]t-test, 2 sided