Mother-infant Signalling During Breastfeeding

Not Applicable

Completed

• Conditions: Breastfeeding Women
• Interventions: Behavioral: Relaxation

• Registration Number: NCT01971216
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Study Start: 2013-12
• Primary Completion: 2015-03
• Study Completion: 2017-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	Relaxation	Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).; 🇲🇾 Kuala Lumpur, Malaysia