- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03578094
Mother and Infant Study Cohort (MISC)-
Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study
This study aims to explore breastfeeding and complementary feeding practices of mothers in the United Arab Emirates (UAE) and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). This research study will follow a prospective cohort approach. Two hundred and fifty mother-infant pairs will be followed for 18 months.
The hypothesis of this research study is that exclusive breastfeeding of the infant will provide potential protective effect against cardiometabolic risk factors. This study will also hypothesize that mothers who exclusively breastfeed their newborns would experience greater postpartum weight and body fat loss than mothers who are not breastfeeding.
Visão geral do estudo
Status
Condições
Descrição detalhada
United Arab Emirates(UAE) is facing two critical situations: high incidence of obesity and chronic diseases and suboptimal infant feeding practices as reported by the Ministry of Health in the UAE. So early identification of preventive markers of cardiometabolic risk factors in breast milk is important for developing early intervention strategies to optimize health care for individuals and communities especially in countries suffering from high rates of obesity and chronic diseases such as the UAE.
The purpose of this study is to prospectively follow up with the mothers and their infants (from 0-18months of infants age). It will explore breastfeeding and complementary feeding practices of mothers in UAE and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). It will examine the components of human milk which might offer a protective benefit against obesity and its health consequences in infancy. It will also evaluate the feeding practices of the mothers and her nutritional status and relates it to their infants' growth and development.
It is expected that this research study will fill an important knowledge gap in the understanding of the feeding practices of mothers and its relation to early-life determinants of obesity and other chronic diseases in the UAE.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Shajah
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Sharjah, Shajah, Emirados Árabes Unidos, 27272
- Hadia Radwan
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The sample population is Emirati and Arab expatriate mothers, aged 19 to 40 years old; visiting Mother and Child Centers (MCH) and Primary Healthcare Centers (PHC) in Dubai and Sharjah.
The selected mothers (who will be recruited during their 3rd trimester) were invited to participate in the study after being consented for their procedures and they will sign on the behalf of their babies
Descrição
Inclusion Criteria:
Pregnant women:
- Emirate nationality or Arab expatriate
- Age: 19-40 years
- Singleton pregnancy
- Within the third trimester of pregnancy (27-42 weeks of gestation)
- Free of chronic diseases (diabetes, hypertension, kidney disease, cancer, or other chronic diseases), autoimmune disorders, or infections with the human immunodeficiency virus, or hepatitis in preconception
Exclusion Criteria:
- Multiple pregnancies (pregnant with two or more fetuses)
- High-risk pregnancy or pre-eclampsia
- History of chronic diseases
- Preterm (<37 weeks of gestation) or late-term (>42 weeks of gestation) infants
- Congenital diseases or any health condition that could deter breastfeeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
relationship between exclusive breastfeeding and maternal serum levels of adiponectin
Prazo: 18 months
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measuring the adiponectin level in the maternal serum at 6 months postpartum
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18 months
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relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin
Prazo: 18 months
|
measuring the adiponectin level and in the infants serum and in the breast milk
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18 months
|
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Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants
Prazo: 18 months
|
measuring the adiponectin serum level in the infants of exclusive breastfeeding group and other breastfeeding patterns
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18 months
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Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )
Prazo: 18 months
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Measuring the weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2 of the mothers at different timelines in relation to breastfeeding duration
|
18 months
|
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Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns
Prazo: 18 months
|
Measuring the weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2 of mothers at different timelines in relation to different breastfeeding patterns
|
18 months
|
|
relationship between exclusive breastfeeding and breast milk levels of adiponectin
Prazo: 18 months
|
measuring the adiponectin level in the breast milk at 6 months postpartum
|
18 months
|
|
Assessment of the anthropometric measurements of the infant according to the breastfeeding patterns
Prazo: 18 months
|
measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns
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18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hadia Radwan, PhD, University of Sharjah
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1501057003-P
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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