Nutrition program for pregnant women and their families
Effectiveness of an Early Intervention Aiming at Promoting Healthy Diet, Lifestyle and Growth of Children Living in Situation of Social Disadvantage : the prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)
This study tests whether a nutrition program that provides education and fresh food can help pregnant women and their families eat healthier and support their children's growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | French Red Cross Academic / other |
| Locations | 2 sites (Lille and 1 other locations) |
| Trial ID | NCT03003117 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a multi-component home visitation nutrition program for socially disadvantaged pregnant women and their families. The program focuses on promoting healthy feeding practices, lifestyle behaviors, and growth in young children through education, provision of fresh produce, and food vouchers. Participants will be randomly assigned to either the intervention group, which receives the comprehensive program, or the control group, which receives standard care. The study will assess the impact of the intervention on maternal diet and child growth over the first two years of life.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in their third trimester from socially disadvantaged backgrounds living in specific areas of Lille and Valenciennes.
Not a fit: Patients who are not socially disadvantaged or those living outside the designated geographic areas may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve nutrition and growth outcomes for children in socially disadvantaged families.
How similar studies have performed: Previous studies have shown success with similar nutrition intervention programs aimed at improving maternal and child health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Lille and 1 other locations
- University Hospital — Lille, France (Completed)
- Valenciennes Hospital, Monaco Hospital maternity — Valenciennes, France (Recruiting)
Study contacts
- Principal investigator: Sandrine Lioret, PhD — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Sandrine Lioret, PhD
- Email: sandrine.lioret@inserm.fr
- Phone: 00 33 1 45 59 51 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.