N/A N=160 Randomized Single-blind Prevention

Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

Schizophrenia · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01368406 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Change in Weight From Baseline to Endpoint — 0.48; 0.48 kg — p=0.055

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: wellness program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federal University of São Paulo
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight From Baseline to Endpoint	0.48; 0.48	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.

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.

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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.