Reducing the Weight of Overweight Schizophrenia Patients

Researchers have found a link between schizophrenia, high blood pressure, and insulin
resistance; this link puts people with schizophrenia at an increased risk for diabetes and
obesity. Weight reduction and maintenance is essential for decreasing these risks. Although
data indicate that nonpharmacological interventions for weight loss are viable options,
studies to determine their effectiveness have not been conducted. This study will determine
the effectiveness of behavioral training for reducing weight in schizophrenia patients. This
study will also determine the effects of weight reduction on cardiovascular risk factors in
this population.

This study comprises two phases. In Phase 1, participants will be randomly assigned to
receive either behavioral training or social skills training for 14 weeks. The behavioral
training will teach participants ways to control their diet and increase their physical
activity. The social skills training will teach participants how to indirectly control their
weight by making social contacts and seeking social support. After 14 weeks, participants in
the social skills training group and any participants who have not lost a specified amount of
weight will complete the study; participants in the behavioral training group who have a 4%
or more weight loss will be enrolled in Phase 2, a 24-month program designed to help
participants maintain their weight loss. All participants in Phase 2 will continue to receive
weekly behavioral training, but they will be randomly assigned to receive either behavioral
training alone or behavioral training combined with biweekly booster treatments where
participants discuss their response to different diet and exercise regimens and researchers
discuss strategies for increasing one's success with the regimens. Interviews, self-report
scales, and blood tests will be used to assess participants at study entry, after Phase 1,
and at the end of the study. Assessments will include quality of life, self esteem, exercise
frequency, blood pressure, serum lipids, and blood glucose.

Inclusion Criteria:

- Diagnosis of schizophrenia or schizoaffective disorder

- Body mass index (BMI) greater than 27

- Stable on antipsychotic drug regimen for at least 1 month prior to study entry

- Parent or guardian willing to provide informed consent, if applicable

- Positive and negative syndrome scale score less than 90

- Willing to use acceptable methods of contraception during the study

Exclusion Criteria:

- Medical contraindication for participating in a weight reduction/exercise program

- Mental retardation

- Current enrollment in another weight management program

- Current use of weight reduction medication

- Unstable cardiovascular or thyroid disease

- Active or end-stage renal disease

- Psychiatric hospitalization within 1 month prior to study entry

- Current use of more than one anti-psychotic medication

- Pregnancy or breastfeeding