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NCT03274739 Clinical Trial

Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood

Childhood Obesity Clinical Trial

Official title:
Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03274739
Other study ID # Creal
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2004
Est. completion date January 18, 2017

Study information
Verified date April 2023
Source Barcelona Institute for Global Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.

Recruitment information / eligibility
Status Completed
Enrollment 2762
Est. completion date January 18, 2017
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - to be resident in one of the study areas - to be at least 16 years old - to have a singleton pregnancy - to wish to deliver in the reference hospital Exclusion Criteria: - to not be fluent in Spanish or other regional languages. - to have followed a programme of assisted reproduction

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Barcelona Institute for Global Health

References & Publications (1)

Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Offspring's body mass index z-score trajectories From birth to 4 years of age
Primary Child cardiometabolic risk score At 4 years
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