Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
torstai 12. heinäkuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
121
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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California
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Long Beach, California, Yhdysvallat, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, Yhdysvallat, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, Yhdysvallat, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Ei väliintuloa: Usual Care
Control group with time-matched study visits
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Active Comparator: 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
Muut nimet:
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Muut: 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
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Mean Weight Change Per Week From Baseline to Termination
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 1. syyskuuta 2010
Ensisijainen valmistuminen (Todellinen)
Torstai 28. toukokuuta 2015
Opintojen valmistuminen (Todellinen)
Torstai 28. toukokuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 15. tammikuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 15. tammikuuta 2010
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 20. tammikuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 9. elokuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 12. heinäkuuta 2018
Viimeksi vahvistettu
Sunnuntai 1. heinäkuuta 2018
Lisää tietoa
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D7358-R
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Lifestyle Balance
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