Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)
12 juillet 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
121
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Long Beach, California, États-Unis, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Sepulveda, California, États-Unis, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, États-Unis, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Usual Care
Control group with time-matched study visits
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Comparateur actif: 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
Autres noms:
|
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Autre: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Weight Change Per Week From Baseline to Termination
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2010
Achèvement primaire (Réel)
28 mai 2015
Achèvement de l'étude (Réel)
28 mai 2015
Dates d'inscription aux études
Première soumission
15 janvier 2010
Première soumission répondant aux critères de contrôle qualité
15 janvier 2010
Première publication (Estimation)
20 janvier 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 août 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D7358-R
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Lifestyle Balance
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University of CologneMedtronicInconnue