Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344500
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2006-06-22
Brief Title:
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Management of Antipsychotic Medication Associated Obesity
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAMAO
Brief Summary:
This program aims to help Veterans who take antipsychotic medications lose weight The investigators use a program based on the American Diabetes Associations 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 minday 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
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 minday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None