Active — Not RecruitingNot Applicable

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

France800 participantsStarted 2017-04-03

Plain-language summary

The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of vegetable consumption (times/day) at age 2 years

Timeframe: 2 years of age

Trial details

NCT IDNCT03003117

SponsorFrench Red Cross

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Diet trials