Mother-infant Signalling During Breastfeeding (MOMS)

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.

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 Overview

• Status: Completed
• Conditions: Breastfeeding Women
• Intervention / Treatment: Behavioral: Relaxation

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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 Outcome Measures

Outcome Measure	Time Frame
Infant temperament measured using the Rothbart questionnaire	12 weeks
Infant appetite assessed using the BEBQ	2,6,12 weeks
Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)	2 weeks

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Mary Fewtrell, MD, UCL Institute of Child Health, London

Publications and helpful links

General Publications

• Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
• Shukri NHM, Wells J, Mukhtar F, Lee MHS, Fewtrell M. Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth. Int Breastfeed J. 2017 Jul 14;12:33. doi: 10.1186/s13006-017-0124-y. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Breastfeeding, relaxation, anxiety, infant growth
• Other Study ID Numbers: 13NT05