- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00344500
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications (MAMAO)
Management of Antipsychotic Medication Associated Obesity
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Rationale: The focus of this project is to develop a strategy to combat medication associated weight gain, the most problematic side effect of the newer antipsychotic medications. Improvements in long-term health outcomes might then be expected to change quality of life, promote treatment adherence, rehabilitative potential, and decrease resource utilization.
Procedures:
Half of the patients will randomized to the behavioral weight loss program (Lifestyle Balance Program) and do the following: Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient Given a 7% weight loss goal Assisted in obtaining a 500 calorie reduction per day Asked to 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
The other half of the patients will be randomized to "Usual Care" and will:
Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional information regarding food pyramids and the amount of calories in fast foods.
Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or exercise Be seen on the same schedule as the experimental group, in order to equalize contact time.
After six months, if patients in the "usual care group" wish to participate in the more rigorous behavioral weight loss program they will be given that opportunity.
Visits:
Time Line:
Each subject will be followed for one year. Healthy Lifestyles courses will take eight weeks to complete. Visits will be monthly for the remaining 12 months Enrollment: 120 patients Course of study: October 2005-October 2008
At Beginning and Termination:
Informed Consent (at start of study only) Psychiatric interviews and assessments Physical Examination Framingham risk assessment for cardiovascular disease Electrocardiogram Lipid Profile, fasting glucose, Hemoglobin A1C
At Each Visit:
Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be reviewed
At Month One and Month Six:
Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments
At Month Nine:
Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram
Clinical Care:
All patients will continue their clinical care with their current psychiatrist and general physician. Medications will not be manipulated for the purpose of this study.
Incentives:
The group participating in the behavioral intervention program will receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
California
-
West Los Angeles, California, Estados Unidos, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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 the West Los Angeles 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Cuidados usuais
|
|
Comparador Ativo: Lifestyle Balance
Behavioral Weight Loss Program
|
Patients randomized 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mean Weight
Prazo: Weekly/Monthly, up to 1 year
|
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
|
Weekly/Monthly, up to 1 year
|
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
Prazo: 12 months
|
General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random.
The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates.
Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data.
We used a linear model of the average rate of change over time (slope) for all comparisons.
To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
|
12 months
|
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
Prazo: 12 months
|
Computed as % body fat at 12 month - % body fat at baseline.
General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random.
The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates.
Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models.
We used a linear model of the average rate of change over time (slope) for all comparisons.
To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publicações e links úteis
Publicações Gerais
- Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. doi: 10.1176/ps.2007.58.11.1498. No abstract available.
- Erickson ZD, Mena SJ, Pierre JM, Blum LH, Martin E, Hellemann GS, Aragaki DR, Firestone L, Lee C, Lee P, Kunkel CF, Ames D. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. J Clin Psychiatry. 2016 Feb;77(2):e183-9. doi: 10.4088/JCP.14m09552.
- Tully A, Smyth S, Conway Y, Geddes J, Devane D, Kelly JP, Jordan F. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013006. doi: 10.1002/14651858.CD013006.pub2.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D3925-R
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