- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274739
Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
April 18, 2023 updated by: Jordi Virgili, Barcelona Institute for Global Health
Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2762
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study included pregnant women recruited between 2003 and 2008 in the four Spanish regions of Asturias, Gipuzkoa, Sabadell and Valencia as part of the population-based INMA ("INfancia y Medio Ambiente") birth cohort study.
The pregnant women were recruited during prenatal visits in the 1st trimester of pregnancy at public health care centers or hospitals.
Mothers were afterwards followed at 3rd trimester, and their children later, and at ages 6 months, 1 and 4 years.
Description
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 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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Pregnant women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Offspring's body mass index z-score trajectories
Time Frame: From birth to 4 years of age
|
From birth to 4 years of age
|
|
Child cardiometabolic risk score
Time Frame: At 4 years
|
At 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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 (Actual)
February 1, 2004
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
January 18, 2017
Study Registration Dates
First Submitted
September 5, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Creal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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