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Mother-infant Signalling During Breastfeeding (MOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01971216
Recruitment Status : Unknown
Verified December 2014 by University College, London.
Recruitment status was:  Recruiting
First Posted : October 29, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Healthy Women Behavioral: Relaxation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : December 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Relaxation tape - audio tape with visual imagery and relaxation exercises


Outcome Measures

Primary Outcome Measures :
  1. Maternal stress and anxiety [ Time Frame: 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)

  2. Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques [ Time Frame: 12 weeks ]
    Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques

  3. Breast milk cortisol concentrations at 12 weeks [ Time Frame: 12 weeks ]
  4. Infant behaviour measured using a 3-day diary at 12 weeks [ Time Frame: 12 weeks ]
  5. Infant weight and body composition measured using stable isotopes at 12 weeks [ Time Frame: 12 weeks ]
  6. 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 Outcome Measures :
  1. Non-nutrient factors in breast milk - leptin and ghrelin [ Time Frame: 2,6,12 weeks ]
  2. Macronutrient composition of breast milk (fat and protein) [ Time Frame: 2,6,12 weeks ]

Other Outcome Measures:
  1. Infant temperament measured using the Rothbart questionnaire [ Time Frame: 12 weeks ]
  2. Infant appetite assessed using the BEBQ [ Time Frame: 2,6,12 weeks ]
  3. Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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). 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

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01971216     History of Changes
Other Study ID Numbers: 13NT05
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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