Adiposity, Breast FeedingNCT03578094
Mother and Infant Study Cohort (MISC)-
An observational study of Adiposity, Breast Feeding, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Breast Feeding
- How many people
- 257 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Dec 2015to 20 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Hadia Radwan
Sharjah city, Shajah, 27272
About this study
Official title: 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.
Read the 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.
- Conditions
- Adiposity, Breast Feeding
- Keywords
- cohort, Noncommunicable diseases, pregnancy, infant, cognition, United Arab Emirates, gestational diabetes
- Medical subject headings
- Obesity, Breast Feeding, Noncommunicable Diseases, Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between exclusive breastfeeding and maternal serum levels of adiponectin
measuring the adiponectin level in the maternal serum at 6 months postpartum
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
relationship between exclusive breastfeeding and breast milk levels of adiponectin
measuring the adiponectin level in the breast milk at 6 months postpartum
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Dec 2015
- Primary completion20 Dec 2017
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adiposity, Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Collaborators
- Al Jalila Foundation
- Responsible party
- Principal investigator, Hadia Radwan, University of Sharjah
- Investigators
- Hadia Radwan, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578094
- Sponsor's protocol ID
- 1501057003-P
- Status last verified
- Jun 2018
- First submitted
- 2 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03578094
- Acronym / sponsor ID
- 1501057003-P
- Conditions
- Adiposity, Breast Feeding
- Keywords
- cohort, Noncommunicable diseases, pregnancy, infant, cognition, United Arab Emirates, gestational diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Collaborators
- Al Jalila Foundation
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- Pregnant women:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadia Radwan, PhD principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, Breast Feeding, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between exclusive breastfeeding and maternal serum levels of adiponectin (time frame: 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.