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Completed

NCT Number: NCT01971216

Mother-infant Signalling During Breastfeeding

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.

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Key information

Conditions

Breastfeeding Women Anxiety Disorders Behavior Breast Feeding Feeding Behavior Mental Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuala Lumpur, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Relaxation

Behavioral

Other names: Relaxation tape - audio tape with visual imagery and relaxation exercises

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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.

Acronym: MOMS

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Oct 29, 2013
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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