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Mother-infant Signalling During Breastfeeding (MOMS)

University College London (UCL) logo

University College London (UCL)

Status

Completed

Conditions

Breastfeeding Women

Treatments

Behavioral: Relaxation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Control
No Intervention group
Description:
Breastfeeding mothers who are not randomised to relaxation intervention
Relaxation
Experimental group
Description:
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
Treatment:
Behavioral: Relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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