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Mother and Infant Study Cohort (MISC)-

22. Juni 2018 aktualisiert von: Hadia Radwan, University of Sharjah

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Adiposity, Breast Feeding

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

257

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Arabische Emirate
- Shajah
  - Sharjah, Shajah, Vereinigte Arabische Emirate, 27272
    - Hadia Radwan

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
relationship between exclusive breastfeeding and maternal serum levels of adiponectin Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 ) Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 18 months	measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns	18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Sharjah

Mitarbeiter

Al Jalila Foundation

Ermittler

Hauptermittler: Hadia Radwan, PhD, University of Sharjah

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2015

Primärer Abschluss (Tatsächlich)

20. Dezember 2017

Studienabschluss (Tatsächlich)

20. Februar 2018

Studienanmeldedaten

Zuerst eingereicht

2. Mai 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2018

Zuerst gepostet (Tatsächlich)

5. Juli 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juli 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt