Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Management of Antipsychotic Medication Associated Obesity - 2

Conditions
-----------------
Diabetes, Obesity, Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Balance


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Control group with time-matched study visits | |
| Active Comparator: Lifestyle Balance<br>Weight management group education and individual counseling | Behavioral: Lifestyle Balance<br>* Patients assigned 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<br>* Other names: Lifestyle Balance Program;|
| Other: Usual Care then Lifestyle Balance<br>Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request. | Behavioral: Lifestyle Balance<br>* Patients assigned 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<br>* Other names: Lifestyle Balance Program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Weight Change Per Week From Baseline to Termination | Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Mean Waist Circumference Change Per Week From Baseline to Termination | Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Mean Serum Insulin Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | 
| Mean Triglycerides Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | 
| Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | 
| Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | 
| Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination | Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared. | Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months. | 
| Change in Mean Total Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Change in Mean Total Exercise Time Per Week From Baseline to Termination | Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 
| Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination | Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination | Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 
| Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination | Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia, Weight Gain, Weight Loss