Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12. července 2018 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
121
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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Long Beach, California, Spojené státy, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, Spojené státy, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, Spojené státy, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Usual Care
Control group with time-matched study visits
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Aktivní komparátor: 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
Ostatní jména:
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Jiný: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Weight Change Per Week From Baseline to Termination
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. září 2010
Primární dokončení (Aktuální)
28. května 2015
Dokončení studie (Aktuální)
28. května 2015
Termíny zápisu do studia
První předloženo
15. ledna 2010
První předloženo, které splnilo kritéria kontroly kvality
15. ledna 2010
První zveřejněno (Odhad)
20. ledna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. srpna 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. července 2018
Naposledy ověřeno
1. července 2018
Více informací
Termíny související s touto studií
Klíčová slova
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .