The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

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.

Conditions

• Diet
• Growth
• Infant
• Physical Activity
• Sedentary Behavior

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• University Hospital, Lille

  collaborator OTHER

• Association Programme MALIN

  collaborator UNKNOWN

• Société Française de Pédiatrie

  collaborator UNKNOWN

• Association Française de Pédiatrie Ambulatoire

  collaborator UNKNOWN

• French Red Cross

  lead OTHER

Principal Investigators

• Sandrine Lioret, PhD · Institut National de la Santé Et de la Recherche Médicale, France

• Delphine Ley, MD, PhD · University Hospital, Lille

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-03

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• France

Study Locations