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Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)

2018年7月12日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

121

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

  • アメリカ
    • California
      • Long Beach、California、アメリカ、90822
        • VA Long Beach Healthcare System, Long Beach, CA
      • Sepulveda、California、アメリカ、91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
      • 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 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

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：独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Usual Care
Control group with time-matched study visits
アクティブコンパレータ：Lifestyle Balance
Weight management group education and individual counseling
行動：Lifestyle Balance
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
他の名前：
  • Lifestyle Balance Program
他の：Usual Care then Lifestyle Balance
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
行動：Lifestyle Balance
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
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 Change Per Week From Baseline to Termination
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

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。

スポンサー

VA Office of Research and Development

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。

一般刊行物

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 (実際)

2010年9月1日

一次修了 (実際)

2015年5月28日

研究の完了 (実際)

2015年5月28日

試験登録日

最初に提出

2010年1月15日

QC基準を満たした最初の提出物

2010年1月15日

最初の投稿 (見積もり)

2010年1月20日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月9日

QC基準を満たした最後の更新が送信されました

2018年7月12日

最終確認日

2018年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D7358-R

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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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