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.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kuala Lumpur, Malásia
- Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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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Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Control
Breastfeeding mothers who are not randomised to relaxation intervention
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Experimental: Relaxation
Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Maternal stress and anxiety
Prazo: 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
Prazo: 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
Prazo: 12 weeks
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12 weeks
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Infant behaviour measured using a 3-day diary at 12 weeks
Prazo: 12 weeks
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12 weeks
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Infant weight and body composition measured using stable isotopes at 12 weeks
Prazo: 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.
Prazo: 2,6,12 weeks
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2,6,12 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Non-nutrient factors in breast milk - leptin and ghrelin
Prazo: 2,6,12 weeks
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2,6,12 weeks
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Macronutrient composition of breast milk (fat and protein)
Prazo: 2,6,12 weeks
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2,6,12 weeks
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Infant temperament measured using the Rothbart questionnaire
Prazo: 12 weeks
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12 weeks
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Infant appetite assessed using the BEBQ
Prazo: 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)
Prazo: 2 weeks
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2 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mary Fewtrell, MD, UCL Institute of Child Health, London
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 13NT05
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