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NCT Number: NCT03578094

Mother and Infant Study Cohort (MISC)-

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.

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Key information

Conditions

Adiposity, Breast Feeding Behavior Body Weight Breast Feeding Diabetes Mellitus Diabetes, Gestational Disease Attributes Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Noncommunicable Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hadia Radwan

Sharjah city, Shajah, 27272, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. relationship between exclusive breastfeeding and maternal serum levels of adiponectin

    Time frame: 18 months

    measuring the adiponectin level in the maternal serum at 6 months postpartum

  2. relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin

    Time frame: 18 months

    measuring the adiponectin level and in the infants serum and in the breast milk

  3. Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants

    Time frame: 18 months

    measuring the adiponectin serum level in the infants of exclusive breastfeeding group and other breastfeeding patterns

  4. Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )

    Time frame: 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

  5. Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns

    Time frame: 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

  6. relationship between exclusive breastfeeding and breast milk levels of adiponectin

    Time frame: 18 months

    measuring the adiponectin level in the breast milk at 6 months postpartum

  7. Assessment of the anthropometric measurements of the infant according to the breastfeeding patterns

    Time frame: 18 months

    measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Collaborators

  • Al Jalila Foundation

Registry information

Official study title

Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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