The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

Launched by FRENCH RED CROSS · Dec 21, 2016

Keywords

ClinConnect Summary

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL) is a study designed to help improve the health and growth of young children by providing support to pregnant women from disadvantaged backgrounds. This trial will involve 800 pregnant women who are in their third trimester, healthy, and at least 18 years old. Participants will receive a special home visitation nutrition program that aims to promote healthier feeding practices and active lifestyles for their children, compared to what they would typically receive in usual care.

To be eligible for this trial, women must live in specific areas around Lille, France, and agree to participate in the study. It's important that they can speak French and are willing to follow the study guidelines. If a woman is pregnant with twins, only one baby will be included in the study. Participants can expect to receive guidance and support in a friendly and informative manner, helping them to make positive changes for their family's health. This trial is not only about nutrition; it also focuses on encouraging physical activity and reducing sedentary behavior in young children, which can lead to better growth and development.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant woman at her 3rd term of pregnancy
• • Healthy
• • Aged ≥ 18 years
• • From a socially disadvantaged background
• • Living in Lille, Lomme, Loos, Faches-Thumesnil, Ronchin, Hellemmes, Haubourdin, La Madeleine, Lambersart, Mons-en-Baroeul, Saint-André-Lez-Lille, Wattignies, Villeneuve-d'Ascq, Marcq-en-Barœul or Wasquehal; or in the Valenciennes conurbation.
• • Willing and able to sign informed consent
• • Who, in the Investigator's judgement, is able to comply with the protocol or study procedures (including French speaking)
• • If twins are born from this pregnancy, only one will be randomly selected for inclusion
• Exclusion Criteria:
• • Pregnant woman under guardianship
• • Participation in any other interventional clinical trial that is not compatible with the participation into the ECAIL study
• • No permanent mailing address
• • Housed in emergency accommodation centres, hotels, movable dwellings or homeless
• • Planning to move outside the study area prior to the child's first birthday
• • Serious illness during pregnancy that could interfere with optimal participation in the ECAIL study
• • Hard drug consumption
• • Multiple pregnancy (≥3 foetuses).