Mother-infant Signalling During Breastfeeding

NCT01971216 | Completed

• 1 other identifier: 13NT05
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding Women

Keywords

Breastfeeding, relaxation, anxiety, infant growth

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Breastfeeding mothers who are not randomised to relaxation intervention

Relaxation

EXPERIMENTAL

Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum

Behavioral: Relaxation

Interventions

Relaxation BEHAVIORAL

Also known as: Relaxation tape - audio tape with visual imagery and relaxation exercises

Relaxation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

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

Kuala Lumpur, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 31161202 DERIVED

• 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.

  PMID: 28725257 DERIVED

MeSH Terms

Conditions

Breast Feeding; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Mental Disorders

Study Officials

• Mary Fewtrell, MD

  UCL Institute of Child Health, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2017
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

MY (1)