NCT03274739

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,762

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

February 1, 2004

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

8.8 years

First QC Date

September 5, 2017

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Offspring's body mass index z-score trajectories

    From birth to 4 years of age

  • Child cardiometabolic risk score

    At 4 years

Study Arms (1)

Pregnant women

Pregnant women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • to not be fluent in Spanish or other regional languages.
  • to have followed a programme of assisted reproduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 21471022BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quality Manager

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

February 1, 2004

Primary Completion

December 1, 2012

Study Completion

January 18, 2017

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share