Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2
This trial is active, not recruiting.
|Conditions||diabetes, obesity, weight gain|
|Treatment||behavioral weight loss program|
|Sponsor||VA Office of Research and Development|
|Start date||September 2010|
|End date||June 2016|
|Trial size||120 participants|
|Trial identifier||NCT01052714, D7358-R|
This program aims to help Veterans who take antipsychotic medications lose weight. We use a program based on the American Diabetes Association's "Diabetes Prevention Program," and we 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 Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Long Beach, CA||VA Long Beach Healthcare System, Long Beach, CA||no longer recruiting|
|Sepulveda, CA||VA Greater Los Angeles Healthcare System, Sepulveda, CA||no longer recruiting|
|West Los Angeles, CA||VA Greater Los Angeles Healthcare System, West Los Angeles, CA||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
time frame: 12 months
Male or female participants from 18 years up to 70 years old.
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 Long Beach, West Los Angeles, Sepulveda, or Downtown 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
|Official title||Management of Antipsychotic Medication Associated Obesity - 2|
|Principal investigator||Donna Ames, MD|
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