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

Obesity Clinical Trial

— MAMAO  

Official title:

Management of Antipsychotic Medication Associated Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344500
• Other study ID #: D3925-R
• Status: Completed
• Phase: N/A
• First received: June 22, 2006
• Last updated: May 12, 2015
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: May 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 West Los Angeles VA hospital.

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:

All patients will receive $10 per visit for reimbursement. A total of 18 visits will yield a maximum of $180 in reimbursement if they stay in the study for a whole year. The group participating in the behavioral intervention program will also receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 the West Los Angeles 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Weight	Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.	Weekly/Monthly, up to 1 year	No
Primary	Change in Predicted Trajectory of Mean BMI Per GLMM Analysis	General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.	12 months	No
Primary	Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis	Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.	12 months	No