Clinical Research Directory
Browse clinical research sites, groups, and studies.
The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)
Sponsor: French Red Cross
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.
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2017-04-03
Completion Date
2026-06
Last Updated
2025-12-01
Healthy Volunteers
Yes
Interventions
Experimental: Intervention Program
The home based educational component from the 3rd trimester of pregnancy to when the child is aged 24 months seeks to build knowledge, skills and social support (social cognitive theory, anticipatory guidance) to the parents regarding feeding practices (focussing on breastfeeding and complementary feeding), and lifestyle behaviors, consistent with the French Nutrition and Health Program (PNNS) guidelines (component 1). Fresh fruit and vegetable baskets, kitchen utensils and cooking devices are made available at a reduced price from the 3rd trimester of pregnancy to when the toddler is aged 24 m (component 2), along with the provision of follow-on formula, baby and family food vouchers from 6 to 24 m (component 3). One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m.
Active comparator: Usual Care
Usual Care reflects the standard treatment currently provided within the frame of the French health care system. One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m. If nutritional questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS.
Locations (2)
University Hospital
Lille, France
Valenciennes Hospital, Monaco Hospital maternity
Valenciennes, France