The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

NCT03003117 | Active Not Recruiting

• 2 other identifiers: 2014-A00849-38n°CPP 03/010/2014
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Infant; Diet; Growth; Breastfeeding; Complementary feeding; Pregnancy; Body mass index; Social disadvantage; Randomized controlled trial; Education; Food vouchers; Physical activity; Screen

Outcome Measures

Primary Outcomes (1)

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

  Measured at 2 years using a food frequency questionnaire

  2 years of age

Secondary Outcomes (15)

• Breastfeeding initiation rate

  Up to 2 years of age

• Predominant and any breastfeeding durations

  Up to 2 years of age

• Age at complementary feeding introduction

  Up to 2 years of age

• Age at first introduction of processed (but not baby-specific) foods

  Up to 2 years of age

• Frequency of vegetable consumption (times/day) at age 1 year

  1 year of age

Study Arms (2)

Intervention Program

EXPERIMENTAL

Experimental: Intervention Program

Behavioral: Experimental: Intervention Program

Usual Care

ACTIVE COMPARATOR

Active comparator: Usual Care

Behavioral: Active comparator: Usual Care

Interventions

Experimental: Intervention Program BEHAVIORAL

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.

Intervention Program

Active comparator: Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• French Red Cross: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Hospital, Lille: collaborator
• Association Programme MALIN: collaborator
• Société Française de Pédiatrie: collaborator
• Association Française de Pédiatrie Ambulatoire: collaborator

Study Sites (2)

University Hospital

Lille, 59037, France

Location

Valenciennes Hospital, Monaco Hospital maternity

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Breast Feeding

Condition Hierarchy (Ancestors)

Behavior; Feeding Behavior

Study Officials

• Sandrine Lioret, PhD

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

  PRINCIPAL INVESTIGATOR

• Delphine Ley, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow, PhD

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 26, 2016
• Study Start: April 3, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)