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

Management of Antipsychotic Medication Associated Obesity

Patrocinadores

Patrocinador principal: VA Office of Research and Development

Fuente VA Office of Research and Development
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio October 2005
Fecha de Terminación September 2009
Fecha de finalización primaria September 2009
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Mean Weight Weekly/Monthly, up to 1 year
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis 12 months
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis 12 months
Inscripción 122
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Behavioral Weight Loss Program

Descripción: 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

Etiqueta de grupo de brazo: Lifestyle Balance

Otro nombre: Lifestyle Balance Program

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 70 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Donna Ames, MD Principal Investigator VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Ubicación
Instalaciones: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Ubicacion Paises

United States

Fecha de verificación

March 2016

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Usual Care

Tipo: No Intervention

Descripción: Usual Care

Etiqueta: Lifestyle Balance

Tipo: Active Comparator

Descripción: Behavioral Weight Loss Program

Acrónimo MAMAO
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov