Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications
Condition: Diabetes; Obesity; Weight Gain
MeSH terms: Obesity; Weight Gain
Study type: Interventional

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.
    

Intervention name(s): Behavioral Weight Loss Program
Intervention type(s): Behavioral
Intervention description(s): 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
Other intervention name(s): Lifestyle Balance Program
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antipsychotic; Bipolar; Diabetes; Mental Illness; Nutrition; Obesity; Schizoaffective; Schizophrenia; Weight Gain; Weight Loss