N/A
Completed N=160
Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01368406 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Change in Weight From Baseline to Endpoint — 0.48; 0.48 kg — p=0.055
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight From Baseline to Endpoint |
0.48; 0.48 | 0.055 |
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.
Data sourced from ClinicalTrials.gov (NCT01368406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.