- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Shajah
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Sharjah, Shajah, Spojené arabské emiráty, 27272
- Hadia Radwan
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
relationship between exclusive breastfeeding and maternal serum levels of adiponectin
Časové okno: 18 months
|
measuring the adiponectin level in the maternal serum at 6 months postpartum
|
18 months
|
relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin
Časové okno: 18 months
|
measuring the adiponectin level and in the infants serum and in the breast milk
|
18 months
|
Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants
Časové okno: 18 months
|
measuring the adiponectin serum level in the infants of exclusive breastfeeding group and other breastfeeding patterns
|
18 months
|
Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )
Časové okno: 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 the mothers at different timelines in relation to breastfeeding duration
|
18 months
|
Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns
Časové okno: 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
Časové okno: 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
Časové okno: 18 months
|
measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns
|
18 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Hadia Radwan, PhD, University of Sharjah
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1501057003-P
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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