Child ObesityNCT03900663
Effect Mode of Delivery and Feeding on Body Composition and Nutritional Status of Children
An observational study of Child Obesity, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Anthropometric measures
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Oct 2021
- 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 2 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: From out patient clinic
Who may be able to join
- Infants of both sexes
- Infants from 2 to 3 years
- Breast fed or formula fed or mixed fed infants
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Obesity
- Being tested
- Anthropometric measures
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measuresDevice
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
| Study group | Role | What they receive |
|---|---|---|
| Breast fed infants | Not described Receives: Device: Anthropometric measures | |
| Formula fed infants | Not described Receives: Device: Anthropometric measures | |
| vaginally delivered infants | Not described Receives: Device: Anthropometric measures | |
| Infants delivered by caesarean section | Not described Receives: Device: Anthropometric measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
Body mass index (BMI) kg/m2
Measured: Through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study startJun 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MR Rassmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900663
- Sponsor's protocol ID
- Delivery,feeding,child obesity
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17327867Goldani 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.
PubMed 21508088Ravelli 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.
PubMed 10685933
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Body Composition of Children in Relation to Mode of Delivery and Feeding in the First 2 Years of Life
- ClinicalTrials.gov ID
- NCT03900663
- Acronym / sponsor ID
- Delivery,feeding,child obesity
- Conditions
- Child Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 Apr 2019 (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.
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast fed infants | – | Device: Anthropometric measures |
| Formula fed infants | – | Device: Anthropometric measures |
| vaginally delivered infants | – | Device: Anthropometric measures |
| Infants delivered by caesarean section | – | Device: Anthropometric measures |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- From out patient clinic
Key inclusion criteria (3 listed)
- Infants of both sexes
- Infants from 2 to 3 years
- Breast fed or formula fed or mixed fed infants
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric measuresMeasure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference | Device | Breast fed infants, Formula fed infants, Infants delivered by caesarean section, vaginally delivered infants |
Primary outcome
Obesity
Time frame: Through one year
Body mass index (BMI) kg/m2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 17327867Harit 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.
- Background: PubMed 21508088Goldani 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.
- Background: PubMed 10685933Ravelli 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Obesity, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maher M. Ahmed, Professor (01066006605, maher.farghali@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity (time frame: Through one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900663, which also lists 3 linked publications.
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 3 Apr 2019.