- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900663
Effect Mode of Delivery and Feeding on Body Composition and Nutritional Status of Children
April 1, 2019 updated by: MR Rassmy, Assiut University
Nutritional Status and Body Composition of Children in Relation to Mode of Delivery and Feeding in the First 2 Years of Life
- Feeding and growth during infancy have been associated with later life body mass index.
- Breastfeeding seems to have a small but consistent protective effect against obesity in children.
- The Cholesterol content of human milk is 6-fold greater than that of the standard infant formulas.
- Infants delivered by caesarean section may be at increased risk of childhood obesity and adulthood obesity.
Study Overview
Detailed Description
- Previous guidelines recommended that infants who are exclusively breast fed for the first 6 months of life, with particular solid foods gradually introduced from 6 months associated with lower childhood fat mass.
- The stated reason for discouraging introduction of solids to infant before 4 months include the risk of excessive weight gain, vulnerability of the gut to infection and increased susceptibility to the development of allergic disease.
- Infants whose dietary pattern was most similar to feeding guidelines, with high frequencies of fresh fruit and vegetables, home prepared foods and breast milk, gained weight and skin fold thickness more rapidly from 6 to12 months than other infants, independent of milk feeding, age of introduction of solids and maternal factors.
- Exclusively breastfed infants had significantly higher Total Cholesterol (TC) level and Low density Lipoprotein level (LDL) and lower High density lipoprotein level (HDL) as compared to mixed-fed infants in the first 6 months of life.
- Exclusive breast feeding seems to have a protective effect against some risk factors for cardiovascular disease in later life, as those who exclusively breastfed had lower level of plasma low density lipoprotein (LDL) cholesterol conc., higher level of high density lipoprotein (HDL) and lower LDL/HDL ratio than those bottle fed.
- Early weaning is related to rapid weight gain in infancy, and this may have implication for childhood obesity.
- Vaginally delivered children are colonised with bacterial strains from the mothers' vagina during delivery in contrast to children delivered by CS, and these differences seem to persist throughout infancy.
- The gut microbiota may have a role in energy harvesting, hence inoculation with maternal microbiota through vaginal delivery may be protective for childhood overweight compared with delivery by CS.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maher M. Ahmed, Professor
- Phone Number: 01066006605
- Email: maher.farghali@med.au.edu.eg
Study Contact Backup
- Name: Osama M. El Asheer, lecturer
- Phone Number: 01001348864
- Email: Osama_elasheer@med.au.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From out patient clinic
Description
Inclusion Criteria:
- Infants of both sexes
- Infants from 2 to 3 years
- Breast fed or formula fed or mixed fed infants
Exclusion Criteria:
- Children less than 2 and more than 3 years ago.
- Children having family history of chronic illness
- Children having family history of metabolic
- Children fed cow milk or buffalo milk.
- Infants delivered preterm.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Breast fed infants
|
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
|
Formula fed infants
|
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
|
vaginally delivered infants
|
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
|
Infants delivered by caesarean section
|
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obesity
Time Frame: Through one year
|
Body mass index (BMI) kg/m2
|
Through one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Harit D, Faridi MM, Aggarwal A, Sharma SB. Lipid profile of term infants on exclusive breastfeeding and mixed feeding: a comparative study. Eur J Clin Nutr. 2008 Feb;62(2):203-9. doi: 10.1038/sj.ejcn.1602692. Epub 2007 Feb 28.
- Goldani HA, Bettiol H, Barbieri MA, Silva AA, Agranonik M, Morais MB, Goldani MZ. Cesarean delivery is associated with an increased risk of obesity in adulthood in a Brazilian birth cohort study. Am J Clin Nutr. 2011 Jun;93(6):1344-7. doi: 10.3945/ajcn.110.010033. Epub 2011 Apr 20.
- Ravelli AC, van der Meulen JH, Osmond C, Barker DJ, Bleker OP. Infant feeding and adult glucose tolerance, lipid profile, blood pressure, and obesity. Arch Dis Child. 2000 Mar;82(3):248-52. doi: 10.1136/adc.82.3.248.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2019
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
April 1, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 1, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Delivery,feeding,child obesity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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