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.

Study Overview

• Status: Completed
• Conditions: Adiposity, Breast Feeding

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.

• Study Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• United Arab Emirates
  • Shajah
    • Sharjah, Shajah, United Arab Emirates, 27272
      • Hadia Radwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relationship between exclusive breastfeeding and maternal serum levels of adiponectin	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	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	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 )	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	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	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	measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns	18 months

Collaborators and Investigators

• Sponsor: University of Sharjah
• Collaborators: Al Jalila Foundation
• Investigators: Principal Investigator: Hadia Radwan, PhD, University of Sharjah

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): February 20, 2018

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: cognition; pregnancy; gestational diabetes; infant; cohort; United Arab Emirates; Noncommunicable diseases
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1501057003-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD)
• IPD Sharing Time Frame: after November 2018
• IPD Sharing Access Criteria: permission from the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No