Mother-infant Signalling During Breastfeeding (MOMS)
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.
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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Kuala Lumpur, Malaysia
- Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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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Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Control
Breastfeeding mothers who are not randomised to relaxation intervention
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Experimentell: Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maternal stress and anxiety
Tidsram: Baselibne to 12 weeks
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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)
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Baselibne to 12 weeks
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Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Tidsram: 12 weeks
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Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
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12 weeks
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Breast milk cortisol concentrations at 12 weeks
Tidsram: 12 weeks
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12 weeks
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Infant behaviour measured using a 3-day diary at 12 weeks
Tidsram: 12 weeks
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12 weeks
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Infant weight and body composition measured using stable isotopes at 12 weeks
Tidsram: 12 weeks
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12 weeks
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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.
Tidsram: 2,6,12 weeks
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2,6,12 weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Non-nutrient factors in breast milk - leptin and ghrelin
Tidsram: 2,6,12 weeks
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2,6,12 weeks
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Macronutrient composition of breast milk (fat and protein)
Tidsram: 2,6,12 weeks
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2,6,12 weeks
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Andra resultatmått
Resultatmått |
Tidsram |
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Infant temperament measured using the Rothbart questionnaire
Tidsram: 12 weeks
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12 weeks
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Infant appetite assessed using the BEBQ
Tidsram: 2,6,12 weeks
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2,6,12 weeks
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Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)
Tidsram: 2 weeks
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2 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mary Fewtrell, MD, UCL Institute of Child Health, London
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 13NT05
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