NCT03900663

Brief 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.
  • Infants delivered by caesarean section may be at increased risk of childhood obesity and adulthood obesity.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

March 21, 2019

Last Update Submit

April 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Obesity

    Body mass index (BMI) kg/m2

    Through one year

Study Arms (4)

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

Interventions

Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference

Breast fed infantsFormula fed infantsInfants delivered by caesarean sectionvaginally delivered infants

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

From out patient clinic

You may qualify if:

  • Infants of both sexes
  • Infants from 2 to 3 years
  • Breast fed or formula fed or mixed fed infants

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 17327867BACKGROUND
  • 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.

    PMID: 21508088BACKGROUND
  • 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.

    PMID: 10685933BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Maher M. Ahmed, Professor

CONTACT

Osama M. El Asheer, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Resident

Study Record Dates

First Submitted

March 21, 2019

First Posted

April 3, 2019

Study Start

June 1, 2019

Primary Completion

March 1, 2021

Study Completion

October 1, 2021

Last Updated

April 3, 2019

Record last verified: 2019-04