Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12 июля 2018 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
121
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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California
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Long Beach, California, Соединенные Штаты, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, Соединенные Штаты, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, Соединенные Штаты, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 70 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Usual Care
Control group with time-matched study visits
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Активный компаратор: 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
Другие имена:
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Другой: Usual Care then Lifestyle Balance
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
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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
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mean Weight Change Per Week From Baseline to Termination
Временное ограничение: 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
Временное ограничение: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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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.
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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 Body Mass Index (BMI) Change Per Week From Baseline to Termination
Временное ограничение: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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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.
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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 Serum Insulin Level Change Per Week From Baseline to Termination
Временное ограничение: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
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Results obtained through VA facility's Outpatient Lab.
The study groups' average serum level changes per week were then compared.
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Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
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Mean Triglycerides Level Change Per Week From Baseline to Termination
Временное ограничение: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
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Results obtained through VA facility's Outpatient Lab.
The study groups' average blood level changes per week were then compared.
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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
Временное ограничение: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
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Results obtained through VA facility's Outpatient Lab.
The study groups' average blood level changes per week were then compared.
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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
Временное ограничение: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
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Results obtained through VA facility's Outpatient Lab.
The study groups' average blood level changes per week were then compared.
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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
Временное ограничение: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
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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.
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Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
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Change in Mean Total Calories Consumed Per Week From Baseline to Termination
Временное ограничение: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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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.
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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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Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
Временное ограничение: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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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.
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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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Change in Mean Total Exercise Time Per Week From Baseline to Termination
Временное ограничение: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
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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.
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Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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.
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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 2 Score Change Per Week From Baseline to Termination
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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.
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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 3 Score Change Per Week From Baseline to Termination
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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.
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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 4 Score Change Per Week From Baseline to Termination
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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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
Временное ограничение: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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Self-reported symptom survey, score range 0 - 63, 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 сентября 2010 г.
Первичное завершение (Действительный)
28 мая 2015 г.
Завершение исследования (Действительный)
28 мая 2015 г.
Даты регистрации исследования
Первый отправленный
15 января 2010 г.
Впервые представлено, что соответствует критериям контроля качества
15 января 2010 г.
Первый опубликованный (Оценивать)
20 января 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 августа 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июля 2018 г.
Последняя проверка
1 июля 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- D7358-R
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Lifestyle Balance
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ЗавершенныйОжирение | Сердечно-сосудистый фактор риска | Риск сахарного диабета
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University of MiamiNational Institute on Disability, Independent Living, and Rehabilitation ResearchЗавершенныйСердечно-сосудистые заболевания | Ожирение | Повреждение спинного мозгаСоединенные Штаты
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Istituto Auxologico ItalianoРекрутингСердечно-сосудистые заболевания | Стресс | Спать | Образ жизни | Физическое бездействие | Питание, ЗдоровоеИталия
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Princess Nourah Bint Abdulrahman UniversityLivenРекрутингСахарный диабет, тип 2Саудовская Аравия
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Amway (China) R&D CenterЗавершенныйОстеоартрит | СаркопенияКитай
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Chinese University of Hong KongЗавершенный
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Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute... и другие соавторыНеизвестныйТравматическое повреждение мозгаСоединенные Штаты
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Creighton UniversityЕще не набираютКачество жизни | Старение | Образ жизни, Здоровый
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University of NebraskaЗавершенныйЗдоровые волонтерыСоединенные Штаты
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Oxford Biomedical Technologies, Inc.РекрутингПрограмма Lifestyle Eating and Performance (LEAP) для лечения синдрома раздраженного кишечника (СРК)СРК - синдром раздраженного кишечникаСоединенные Штаты