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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
研究概览
简要总结
Primary hypotheses
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control
Breastfeeding mothers who are not randomised to relaxation intervention
Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
干预措施: Relaxation (Behavioral)
结局指标
主要结局
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
时间窗: 12 weeks
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Breast milk cortisol concentrations at 12 weeks
时间窗: 12 weeks
Infant behaviour measured using a 3-day diary at 12 weeks
时间窗: 12 weeks
Infant weight and body composition measured using stable isotopes at 12 weeks
时间窗: 12 weeks
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.
时间窗: 2,6,12 weeks
Maternal stress and anxiety
时间窗: Baselibne to 12 weeks
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)
次要结局
- Non-nutrient factors in breast milk - leptin and ghrelin(2,6,12 weeks)
- Macronutrient composition of breast milk (fat and protein)(2,6,12 weeks)