Mother-infant Signalling During Breastfeeding (MOMS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01971216
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy Breastfeeding Women
Behavioral: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Maternal stress and anxiety [ Time Frame: Baselibne to 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques

  • Breast milk cortisol concentrations at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Infant behaviour measured using a 3-day diary at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Infant weight and body composition measured using stable isotopes at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-nutrient factors in breast milk - leptin and ghrelin [ Time Frame: 2,6,12 weeks ] [ Designated as safety issue: No ]
  • Macronutrient composition of breast milk (fat and protein) [ Time Frame: 2,6,12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Infant temperament measured using the Rothbart questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Infant appetite assessed using the BEBQ [ Time Frame: 2,6,12 weeks ] [ Designated as safety issue: No ]
  • Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Relaxation tape - audio tape with visual imagery and relaxation exercises

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971216

Contacts
Contact: Nurul Husna Mohd Shukri, MSc #44 207905 ext 2389 nurul.shukri.12@ucl.ac.uk
Contact: Mary Fewtrell, MD #44 207905 ext 2389 m.fewtrell@ucl.ac.uk

Locations
Malaysia
Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM). Not yet recruiting
Kuala Lumpur, Malaysia
Contact: Mary Huang So Lee       huang@medic.upm.edu.my   
Principal Investigator: Mary Huang So Lee         
Sub-Investigator: Firdaus Mukhtar         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Mary Fewtrell, MD UCL Institute of Child Health, London
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01971216     History of Changes
Other Study ID Numbers: 13NT05
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
Breastfeeding, relaxation, anxiety, infant growth

ClinicalTrials.gov processed this record on August 21, 2014