Clinical trial NCT03578094: Mother and Infant Study Cohort (MISC)-
Official title: Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adiposity, Breast Feeding
Keywords: cohort
Noncommunicable diseases
pregnancy
infant
cognition
United Arab Emirates
gestational diabetes
Lead sponsor: University of Sharjah
Sponsor class: OTHER
Collaborators: name: Al Jalila Foundation
First posted: 2018-07-05
Enrollment: 257
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: relationship between exclusive breastfeeding and maternal serum levels of adiponectin
timeFrame: 18 months
measure: relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin
timeFrame: 18 months
measure: Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants
timeFrame: 18 months
measure: Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )
timeFrame: 18 months
measure: Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns
timeFrame: 18 months
measure: relationship between exclusive breastfeeding and breast milk levels of adiponectin
timeFrame: 18 months
measure: Assessment of the anthropometric measurements of the infant according to the breastfeeding patterns
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Hadia Radwan
state: Shajah
Study officials:
affiliation: University of Sharjah
name: Hadia Radwan, PhD
role: PRINCIPAL_INVESTIGATOR
References: