Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12. juli 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
121
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Long Beach, California, Forente stater, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, Forente stater, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, Forente stater, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Usual Care
Control group with time-matched study visits
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Aktiv komparator: 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
Andre navn:
|
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Annen: 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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Weight Change Per Week From Baseline to Termination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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.
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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
Tidsramme: 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.
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2010
Primær fullføring (Faktiske)
28. mai 2015
Studiet fullført (Faktiske)
28. mai 2015
Datoer for studieregistrering
Først innsendt
15. januar 2010
Først innsendt som oppfylte QC-kriteriene
15. januar 2010
Først lagt ut (Anslag)
20. januar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juli 2018
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D7358-R
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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