Breastfeeding Women
Conditions
Keywords
Breastfeeding, relaxation, anxiety, infant growth
Brief summary
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.
Interventions
BEHAVIORALRelaxation
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maternal stress and anxiety | 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) |
| Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques | 12 weeks | Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques |
| 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 | — |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Infant appetite assessed using the BEBQ | 2,6,12 weeks |
| Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS) | 2 weeks |
| Infant temperament measured using the Rothbart questionnaire | 12 weeks |
Countries
Malaysia
Outcome results
None listed