Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2013-12-31
2017-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Control
Breastfeeding mothers who are not randomised to relaxation intervention
No interventions assigned to this group
Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
Relaxation
Interventions
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Relaxation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 smokes Mothers who do not exclusively breastfeed their infant
\-
18 Years
40 Years
FEMALE
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Mary Fewtrell, MD
Role: PRINCIPAL_INVESTIGATOR
UCL Institute of Child Health, London
Locations
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Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
Kuala Lumpur, , Malaysia
Countries
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References
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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.
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.
Other Identifiers
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13NT05
Identifier Type: -
Identifier Source: org_study_id
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