NCT00344500

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

Management of Antipsychotic Medication Associated Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetes
• Obesity
• Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Weight Loss 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

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-06-26
• Last updated: 2016-04-06
• Results posted: 2015-05-18

Locations

1 site across 1 country: United States