Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12 de julio de 2018 actualizado por: VA Office of Research and Development
Management of Antipsychotic Medication Associated Obesity - 2
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
121
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
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Long Beach, California, Estados Unidos, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, Estados Unidos, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, Estados Unidos, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Usual Care
Control group with time-matched study visits
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|
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Comparador activo: Lifestyle Balance
Weight management group education and individual counseling
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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
Otros nombres:
|
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Otro: Usual Care then Lifestyle Balance
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
|
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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Weight Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
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Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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Mean Waist Circumference Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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
Periodo de tiempo: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
|
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
Periodo de tiempo: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
|
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.
|
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Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
|
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.
|
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Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
|
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.
|
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Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
|
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
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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.
|
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Change in Mean Total Exercise Time Per Week From Baseline to Termination
Periodo de tiempo: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
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.
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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
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
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Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
|
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WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
|
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WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
|
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WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
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Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
Clinician-assessed symptom survey, score range 18 - 126, best to worst.
The study groups' average score changes per week were then compared.
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Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Periodo de tiempo: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
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.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Kwan CL, Gelberg HAL, Rosen JA, Chamberlin V, Shah C, Nguyen C, Pierre JM, Erickson ZD, Mena SJ, King M Jr, Arnold I, Baker MR, Meyer HB, Ames D. Nutritional counseling for adults with severe mental illness: key lessons learned. J Acad Nutr Diet. 2014 Mar;114(3):369-374. doi: 10.1016/j.jand.2013.12.005. No abstract available.
- Gelberg HA, Kwan CL, Mena SJ, Erickson ZD, Baker MR, Chamberlin V, Nguyen C, Rosen JA, Shah C, Ames D. Meal replacements as a weight loss tool in a population with severe mental illness. Eat Behav. 2015 Dec;19:61-4. doi: 10.1016/j.eatbeh.2015.06.009. Epub 2015 Jul 2.
- Erickson ZD, Kwan CL, Gelberg HA, Arnold IY, Chamberlin V, Rosen JA, Shah C, Nguyen CT, Hellemann G, Aragaki DR, Kunkel CF, Lewis MM, Sachinvala N, Sonza PA, Pierre JM, Ames D. A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity. J Gen Intern Med. 2017 Apr;32(Suppl 1):32-39. doi: 10.1007/s11606-016-3960-3.
- Tessier JM, Erickson ZD, Meyer HB, Baker MR, Gelberg HA, Arnold IY, Kwan C, Chamberlin V, Rosen JA, Shah C, Hellemann G, Lewis MM, Nguyen C, Sachinvala N, Amrami B, Pierre JM, Ames D. Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness. Mil Med. 2017 Sep;182(9):e1738-e1744. doi: 10.7205/MILMED-D-16-00405.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2010
Finalización primaria (Actual)
28 de mayo de 2015
Finalización del estudio (Actual)
28 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2010
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2010
Publicado por primera vez (Estimar)
20 de enero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D7358-R
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .