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Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications (MAMAO)

2016年3月8日 更新者:VA Office of Research and Development

Management of Antipsychotic Medication Associated Obesity

This program aims to help Veterans who take antipsychotic medications lose weight. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators 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 West Los Angeles VA hospital.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

122

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • West Los Angeles、California、アメリカ、90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:いつものお手入れ
アクティブコンパレータ: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

  • 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
他の名前:
  • Lifestyle Balance Program

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Weight
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Donna Ames, MD、VA Greater Los Angeles Healthcare System, West Los Angeles, CA

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年10月1日

一次修了 (実際)

2009年9月1日

研究の完了 (実際)

2009年9月1日

試験登録日

最初に提出

2006年6月22日

QC基準を満たした最初の提出物

2006年6月22日

最初の投稿 (見積もり)

2006年6月26日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年4月6日

QC基準を満たした最後の更新が送信されました

2016年3月8日

最終確認日

2016年3月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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