Mother-infant Signalling During Breastfeeding (MOMS)
Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.
Primary hypotheses
1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)
Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.
調査の概要
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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Kuala Lumpur、マレーシア
- Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
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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:
Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of >2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).
No current or recent involvement in other research studies that could potentially affect any of outcome measures.
Mother speaks and understands either English only or English and Malay (some questionnaires are in English)
Exclusion Criteria:
Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.
Mother smokes Mothers who do not exclusively breastfeed their infant
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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：他の
- 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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介入なし：Control
Breastfeeding mothers who are not randomised to relaxation intervention
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実験的：Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
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他の名前：
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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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Maternal stress and anxiety
時間枠：Baselibne to 12 weeks
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Maternal stress and anxiety assessed using the Cohen's Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) respectively (change in score from baseline to end-point at 12 weeks)
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Baselibne to 12 weeks
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Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
時間枠：12 weeks
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Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
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12 weeks
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Breast milk cortisol concentrations at 12 weeks
時間枠：12 weeks
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12 weeks
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Infant behaviour measured using a 3-day diary at 12 weeks
時間枠：12 weeks
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12 weeks
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Infant weight and body composition measured using stable isotopes at 12 weeks
時間枠：12 weeks
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12 weeks
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Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks.
時間枠：2,6,12 weeks
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2,6,12 weeks
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二次結果の測定
結果測定 |
時間枠 |
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Non-nutrient factors in breast milk - leptin and ghrelin
時間枠：2,6,12 weeks
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2,6,12 weeks
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Macronutrient composition of breast milk (fat and protein)
時間枠：2,6,12 weeks
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2,6,12 weeks
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その他の成果指標
結果測定 |
時間枠 |
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Infant temperament measured using the Rothbart questionnaire
時間枠：12 weeks
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12 weeks
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Infant appetite assessed using the BEBQ
時間枠：2,6,12 weeks
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2,6,12 weeks
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Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)
時間枠：2 weeks
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2 weeks
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協力者と研究者
捜査官
- 主任研究者：Mary Fewtrell, MD、UCL Institute of Child Health, London
出版物と役立つリンク
一般刊行物
- Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
- Shukri NHM, Wells J, Mukhtar F, Lee MHS, Fewtrell M. Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth. Int Breastfeed J. 2017 Jul 14;12:33. doi: 10.1186/s13006-017-0124-y. eCollection 2017.
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 (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
本研究に関する用語
その他の研究ID番号
- 13NT05
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