Mother-infant Signalling During Breastfeeding

Breastfeeding Women Clinical Trial

— MOMS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971216
• Other study ID #: 13NT05
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: July 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding Women

Intervention

Behavioral:
• Relaxation

Locations

Country	Name	City	State
Malaysia	Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant temperament measured using the Rothbart questionnaire		12 weeks
Other	Infant appetite assessed using the BEBQ		2,6,12 weeks
Other	Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)		2 weeks
Primary	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
Primary	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
Primary	Breast milk cortisol concentrations at 12 weeks		12 weeks
Primary	Infant behaviour measured using a 3-day diary at 12 weeks		12 weeks
Primary	Infant weight and body composition measured using stable isotopes at 12 weeks		12 weeks
Primary	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	Non-nutrient factors in breast milk - leptin and ghrelin		2,6,12 weeks
Secondary	Macronutrient composition of breast milk (fat and protein)		2,6,12 weeks