SCALE: Small Changes and Lasting Effects (SCALE)
調査の概要
詳細な説明
SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The study will examine the possibility and acceptance of a mindful eating intervention in African American and Latino participants. We will test whether positive thinking can protect participants against the negative impact that stress and depression can have on making positive behavior changes such as mindful eating and physical activity.
Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity. Participants are enrolled for 12 months and are randomized to one of two study groups.
Group 1: Will choose one of ten small change eating strategies, a physical activity goal and will receive the positive affect/self affirmation component.
Group 2: Will choose one of ten small change eating strategies and a physical activity goal
For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at 646-962-5070 or email ror2023@med.cornell.edu
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Bronx、New York、アメリカ、10451
- Lincoln Medical and Mental Health Center
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Bronx、New York、アメリカ、10455
- East Side House Settlement
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Bronx、New York、アメリカ、10457
- Iglesia Congregacion Cristiana del Bronx
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New York、New York、アメリカ、10026
- Renaissance Health Care Network
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New York、New York、アメリカ、10030
- Abyssinian Baptist Church
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New York、New York、アメリカ、10035
- Metropolitan Methodist Church
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Eligibility Criteria:
Black or Latino community-dwelling subjects who are 21 years or older and have a body mass index of >25 but <50 or considered to be obese or overweight are be eligible for study participation. All participants must be able to participate in physical activity and Must be fluent in English or Spanish.
Exclusion Criteria:
Subjects will be excluded if:
- Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol addiction
- Pregnant or are planning to become pregnant within the year
- Participating in another weight loss program or trial
- On medications for obesity
- Have a history of bulimia;
- history of surgery for obesity;
- Have severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, congestive heart failure.
- They live in an institutional setting (nursing home, prison or group home).
Have severe disease or are terminally ill, including stroke, myocardial infarction, coronary artery disease requiring angioplasty.
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研究計画
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Group 1
Subjects in will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component. eating/physical activity/positive affect/self-affirmation group. |
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
他の名前：
|
|
実験的：Group 2
Subjects will be randomized to the small change eating strategy and a physical activity goal. eating/physical activity group. No intervention, just the eating strategy and physical activity components. |
Subjects will be randomized to the small change eating strategy and a physical activity goal.
他の名前：
|
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 |
|---|---|---|
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Percent weight loss
時間枠：12 months
|
The primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity.
|
12 months
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。