慢性腎臓病における多文化の健康的な食事
慢性腎臓病の人種/民族的少数派における多文化の健康的な食事 (抗炎症食パターン) の実現可能性と受容性
調査の概要
詳細な説明
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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The Bronx、New York、アメリカ、10461
- Montefiore Medical Center
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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
説明
包含基準:
- 18歳以上
- CKD ステージ 3 (推定糸球体濾過率 (GFR) < 60 - >30 ml/min/1.73m2)
- ブロンクスでの滞在
- 英語またはスペイン語を話す
- 書面によるインフォームド コンセントを提供する
除外基準:
- -高カリウム血症の病歴、またはベースラインの血清K > 4.6
- -CKDステージ4以上(eGFR <30 ml / min / 1.73 m2)
- 食生活を変えたくない
- 腎移植の歴史
- コントロール不良の糖尿病(HbA1c >9%)またはインスリンの使用
- コントロールされていない高血圧 (BP >150 /90 mmHg)
- -重度の慢性疾患、識字率の低さ、または食事の変更や研究活動の完了を妨げるその他の状態
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:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
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他の:すべての参加者が介入を受けます
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食品ベースの成分は、進行中の MHD 研究 (NCT03240406) の抗炎症食に似ています。これは、参加者の文化的背景に特有の抗炎症食品/食品成分に焦点を当てて、動物性および高飽和脂肪食品を制限することを強調しています。 .
食事は、ナトリウム摂取量の低下に焦点を当てるなど、CKD 人口のニーズにも合わせて調整されます。
介入(食事カウンセリング)は、経験豊富な腎疾患栄養士によって行われます。
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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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Feasibility of Dietary Intervention
時間枠:From baseline (pre-intervention) to 2 months (post-intervention)
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Feasibility will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index (E-DII®). The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records (i.e., food diaries). The Energy Adjusted Dietary Inflammatory Index (E-DII®) quantifies the inflammatory potential of a person's diet while adjusting for total energy intake. Scores range from -8.87 (maximally anti-inflammatory) to +7.98 (maximally pro-inflammatory). Higher (positive) scores indicate greater adherence to a pro-inflammatory dietary pattern (e.g., highly processed or fried foods, sugary beverages) and are associated with poorer health outcomes, whereas lower (negative) scores indicate greater adherence to an anti-inflammatory dietary pattern (e.g., leafy greens, fruits, fish) and are associated with better health outcomes. |
From baseline (pre-intervention) to 2 months (post-intervention)
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Acceptability of Dietary Intervention
時間枠:2 months post baseline
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Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire.
Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing; whether they liked the diet, in general; liked using herbs/spices that they had not used before; and would recommend the diet to family/friends.
Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree).
The number/percentage of participants selecting each category will be tabulated.
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2 months post baseline
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Potassium Level
時間枠:2-4 weeks after first session with nutritionist (onset of intervention)
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A serum potassium will be assessed 2-4 weeks after starting the diet as an added safety measure.
Results are summarized in milliequivalents/liter (mEq/L).
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2-4 weeks after first session with nutritionist (onset of intervention)
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協力者と研究者
捜査官
- 主任研究者:Tanya Johns, MD、Montefiore Medical Center
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021-12753
- K23DK124644-01A1 (米国 NIH グラント/契約)
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?
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
米国FDA規制機器製品の研究
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