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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(No Intervention)
Usual Care
(Active Comparator)
Weight management education and counseling
behavioral weight loss program Lifestyle Balance Program
Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -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

Primary Outcomes

Weight Loss
time frame: 12 months

Eligibility Criteria

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

Additional Information

Official title Management of Antipsychotic Medication Associated Obesity - 2
Principal investigator Donna Ames, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.