Mother-infant Signalling During Breastfeeding

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breastfeeding Women

Intervention / Treatment
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* Behavioral: Relaxation


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Breastfeeding mothers who are not randomised to relaxation intervention | |
| Experimental: Relaxation<br>Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum | Behavioral: Relaxation<br> <br> * Other names: Relaxation tape - audio tape with visual imagery and relaxation exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal stress and anxiety | 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) | Baselibne to 12 weeks | 
| Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques | Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques | 12 weeks | 
| Breast milk cortisol concentrations at 12 weeks |  | 12 weeks | 
| Infant behaviour measured using a 3-day diary at 12 weeks |  | 12 weeks | 
| Infant weight and body composition measured using stable isotopes at 12 weeks |  | 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. |  | 2,6,12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, relaxation, anxiety, infant growth