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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kuala Lumpur、马来西亚
- Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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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学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control
Breastfeeding mothers who are not randomised to relaxation intervention
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实验性的：Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Maternal stress and anxiety
大体时间：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
大体时间：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
大体时间：12 weeks
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12 weeks
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Infant behaviour measured using a 3-day diary at 12 weeks
大体时间：12 weeks
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12 weeks
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Infant weight and body composition measured using stable isotopes at 12 weeks
大体时间：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.
大体时间：2,6,12 weeks
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2,6,12 weeks
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次要结果测量
结果测量 |
大体时间 |
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Non-nutrient factors in breast milk - leptin and ghrelin
大体时间：2,6,12 weeks
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2,6,12 weeks
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Macronutrient composition of breast milk (fat and protein)
大体时间：2,6,12 weeks
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2,6,12 weeks
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其他结果措施
结果测量 |
大体时间 |
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Infant temperament measured using the Rothbart questionnaire
大体时间：12 weeks
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12 weeks
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Infant appetite assessed using the BEBQ
大体时间：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)
大体时间：2 weeks
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2 weeks
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合作者和调查者
调查人员
- 首席研究员：Mary Fewtrell, MD、UCL Institute of Child Health, London
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 13NT05
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