Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12. Juli 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
121
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
California
-
Long Beach, California, Vereinigte Staaten, 90822
- VA Long Beach Healthcare System, Long Beach, CA
-
Sepulveda, California, Vereinigte Staaten, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
-
West Los Angeles, California, Vereinigte Staaten, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Usual Care
Control group with time-matched study visits
|
|
|
Aktiver Komparator: Lifestyle Balance
Weight management group education and individual counseling
|
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
Andere Namen:
|
|
Sonstiges: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean Weight Change Per Week From Baseline to Termination
Zeitfenster: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
|
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
|
|
Mean Waist Circumference Change Per Week From Baseline to Termination
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
|
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
|
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
|
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
|
Change in Mean Total Exercise Time Per Week From Baseline to Termination
Zeitfenster: 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.
|
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
Zeitfenster: 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.
|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
|
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
|
|
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. September 2010
Primärer Abschluss (Tatsächlich)
28. Mai 2015
Studienabschluss (Tatsächlich)
28. Mai 2015
Studienanmeldedaten
Zuerst eingereicht
15. Januar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Januar 2010
Zuerst gepostet (Schätzen)
20. Januar 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. August 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juli 2018
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D7358-R
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lifestyle Balance
-
University of CologneMedtronicUnbekannt