Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications

Rationale: The focus of this project is to develop a strategy to combat medication
associated weight gain, the most problematic side effect of the newer antipsychotic
medications. Improvements in long-term health outcomes might then be expected to change
quality of life, promote treatment adherence, rehabilitative potential, and decrease
resource utilization.

Procedures:

Half of the patients will randomized to the behavioral weight loss program (Lifestyle
Balance Program) and do the following: Meet with their psychiatrist and a nutritionist who
will go over diet recommendations with the patient Given a 7% weight loss goal Assisted in
obtaining a 500 calorie reduction per day Asked to exercise for at least 30 min/day, at
least 5 days a week Maintain weekly food and exercise diaries Be quizzed on their knowledge
of healthy eating habits and nutrition

The other half of the patients will be randomized to "Usual Care" and will:

Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional
information regarding food pyramids and the amount of calories in fast foods.

Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or
exercise Be seen on the same schedule as the experimental group, in order to equalize
contact time.

After six months, if patients in the "usual care group" wish to participate in the more
rigorous behavioral weight loss program they will be given that opportunity.

Visits:

Time Line:

Each subject will be followed for one year. Healthy Lifestyles courses will take eight weeks
to complete. Visits will be monthly for the remaining 12 months Enrollment: 120 patients
Course of study: October 2005-October 2008

At Beginning and Termination:

Informed Consent (at start of study only) Psychiatric interviews and assessments Physical
Examination Framingham risk assessment for cardiovascular disease Electrocardiogram Lipid
Profile, fasting glucose, Hemoglobin A1C

At Each Visit:

Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be
reviewed

At Month One and Month Six:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments

At Month Nine:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram

Clinical Care:

All patients will continue their clinical care with their current psychiatrist and general
physician. Medications will not be manipulated for the purpose of this study.

Incentives:

The group participating in the behavioral intervention program will receive rewards for
achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal
replacements.

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