Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
調査の概要
詳細な説明
We propose a randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 12 months postpartum. We will enroll 280 pregnant mothers who successfully quit smoking during this pregnancy (≤28 weeks). After the pre-test, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=140) or the attention control group (N=140). The intervention group will receive a multicomponent intervention consisting of breastfeeding education, lactation counseling, social support, contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care, with attention and monetary earnings similar to the intervention group. Both groups will receive usual care (i.e., information, education, and Quitline) for postpartum smoking relapse. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.
Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Aim 2 is to examine potential mediating mechanisms: reductions in stress and negative affect, enhancing mother-infant bonding and maternal sensitivity, and maternal weight retention. Aim 3 is to assess the effects of breastfeeding promotion intervention on maternal and infant health among ex-smoking mothers. This innovative study can yield promising data to support a new intervention to prevent postpartum smoking relapse. It has the potential to reduce smoking-related harms to both the mother and the infant, maximize the protective effects of breastfeeding on infant health and development, and narrow health disparities.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Xiaozhong Wen
- 電話番号:716-829-6811
- メール:xiaozhon@buffalo.edu
研究場所
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New York
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Buffalo、New York、アメリカ、14214
- 募集
- Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
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コンタクト:
- Xiaozhong Wen
- 電話番号:716-829-6811
- メール:xiaozhon@buffalo.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Be pregnant
- Be 18 years or older
- Have quit smoking cigarettes during this pregnancy
- Be willing to receive infant care and breastfeeding education
- Be able to read, listen, and talk in English
Exclusion Criteria:
- Medical conditions contraindicating breastfeeding, such as HIV infection, active tuberculosis, and breast removal
- Current heavy drinking (≥4 standard drinks on any day or ≥8 standard drinks per week)
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
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プラセボコンパレーター:プラセボ対照群に注意
一般的な乳児ケアのカウンセリングとサポート
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The control group will receive instructions on general pregnancy and infant care from this project
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実験的:Breastfeeding intervention grou
A multicomponent behavioral intervention to promote breastfeeding
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The intervention group will receive a multicomponent intervention promoting breastfeeding, including education, lactation counseling, social support, breastfeeding-contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants).
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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 |
時間枠 |
|---|---|
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Number of participants reporting to smoke
時間枠:12 months postpartum
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12 months postpartum
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of participants reporting to breastfeed
時間枠:12months postpartum
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12months postpartum
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Systolic blood pressure level
時間枠:12 months postpartum
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12 months postpartum
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Diastolic blood pressure level
時間枠:12 months postpartum
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12 months postpartum
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Infant weight-for-length z-score
時間枠:12 months of age
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12 months of age
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Infant length-for-age z-score
時間枠:12 months of age
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12 months of age
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Infant head circumference
時間枠:12 months of age
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12 months of age
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Infant arm circumference
時間枠:12 months of age
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12 months of age
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Number of infants with bronchiolitis
時間枠:12 months of age
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12 months of age
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協力者と研究者
捜査官
- 主任研究者:Xiaozhong Wen、State University of New York at Buffalo
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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