N/A
N=122
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications
Diabetes · Obesity · Weight Gain
Bottom Line
View on ClinicalTrials.gov: NCT00344500 ↗Enrolled (actual)
122
Serious AEs
14.8%
Results posted
May 2015
Primary outcome: Primary: Mean Weight — 235.22; 232.1; 235.95; 233.41 Pounds — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Weight Loss Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weight |
235.22; 232.1; 235.95; 233.41; 232.3; 233.34 | <0.01 sig |
| PRIMARY Change in Predicted Trajectory of Mean BMI Per GLMM Analysis |
0.6; -1.7 | — |
| PRIMARY Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis |
1.5; -2 | — |
Summary
This program aims to help Veterans who take antipsychotic medications lose weight. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the West Los Angeles VA hospital.
Eligibility Criteria
Inclusion Criteria
- Must be a Veteran
- Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
- Age 18-70
- Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
- Experienced weight gain since treatment with SGA's
- Inpatient or outpatient at the West Los Angeles VA
- Competent to sign informed consent
Exclusion Criteria
- Have recently been diagnosed with schizophrenia (less than 1 year)
- Are pregnant or breast feeding a baby
- Have a medically unstable condition
Data sourced from ClinicalTrials.gov (NCT00344500). 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.