Mother-infant Signalling During Breastfeeding

N/ACompletedNCT01971216

University College, London64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Breastfeeding Women

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Outcomes

Primary Outcomes

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)

Time frame: Baselibne to 12 weeks

Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques

Time frame: 12 weeks

Breast milk cortisol concentrations at 12 weeks

Time frame: 12 weeks

Infant behaviour measured using a 3-day diary at 12 weeks

Time frame: 12 weeks

Infant weight and body composition measured using stable isotopes at 12 weeks

Time frame: 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.

Time frame: 2,6,12 weeks

Secondary Outcomes

Non-nutrient factors in breast milk - leptin and ghrelin

Time frame: 2,6,12 weeks

Macronutrient composition of breast milk (fat and protein)

Time frame: 2,6,12 weeks

Mother-infant Signalling During Breastfeeding

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes