Adiposity, Breast Feeding Clinical Trial
Official title:
Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study
| Verified date | June 2018 |
| Source | University of Sharjah |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 257 |
| Est. completion date | February 20, 2018 |
| Est. primary completion date | December 20, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Arab Emirates | Hadia Radwan | Sharjah | Shajah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sharjah | Al Jalila Foundation |
United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | relationship between exclusive breastfeeding and maternal serum levels of adiponectin | measuring the adiponectin level in the maternal serum at 6 months postpartum | 18 months | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | relationship between exclusive breastfeeding and breast milk levels of adiponectin | measuring the adiponectin level in the breast milk at 6 months postpartum | 18 months | |
| Primary | 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 |