The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

Not Applicable

Recruiting

• Conditions: Physical Activity; Growth; Infant; Sedentary Behavior; Diet

• Registration Number: NCT03003117
• Lead Sponsor: French Red Cross

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.

Detailed Description

This randomized controlled trial will test an early home based multi-component intervention program designed to promote healthy feeding practices and lifestyle behaviors in socially disadvantaged pregnant women and their families. It first seeks to build knowledge, skills and social support regarding maternal diet and feeding practices (with a focus on breastfeeding and complementary feeding), and lifestyle behaviors, within the frame of the French Nutrition and Health Program (Programme National Nutrition Santé, PNNS) while accounting for the cultural background and barriers of the targeted population (component 1). It also involves fresh fruit and vegetable baskets, kitchen utensils and cooking devices, being made available at a reduced price from the 3rd trimester of pregnancy to when the toddler is aged 24 months (component 2), along with the provision of follow-on formula, baby and family food vouchers from 6 to 24 months (component 3). The intervention group (n=400) will benefit from these 3 program components. The control group (n=400) will receive usual care, restricted to general information on healthy eating provided by the food guides of the PNNS. The ECAIL study will assess the program's effectiveness on lifestyle behaviors and growth in the first 2 years of life.

Noteworthy, the program evaluated for effectiveness with the ECAIL trial is an existing program, called the MALIN program (https://www.programme-malin.com/), which has been progressively implemented in mainland France since 2012, to the exception of the ECAIL study area. Since 2019, counselling on movement behaviors, including the promotion of physical activity and the prevention of sedentary behaviors (e.g. screen time), has been added to the diet and feeding practices educational component; discount vouchers have further encompassed other healthy foods and products appropriate for all family members; and online sales for kitchen utensils and cooking devices have been started too.

Study Timeline

• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Study Start: 2017-04-03
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-09-02
• Primary Completion: 2027-07
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of vegetable consumption (times/day) at age 2 years	2 years of age	Measured at 2 years using a food frequency questionnaire

Secondary Outcome Measures

Name	Time	Method
Dietary patterns at age 2 years	2 years of age	Measured at 2 years using a food frequency questionnaire
Age at first introduction of processed (but not baby-specific) foods	Up to 2 years of age	Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires
BMI at age 2 years	2 years of age	Weight, length and BMI measured at different time points from birth to 2 y
BMI curves from birth to 2 y	Up to 2 years of age	BMI measured at different time points from birth to 2 y
Weight growth velocity over the six first months of life	Up to 6 months of age	Weight measured at different time points from birth to 6 months of age
Age at complementary feeding introduction	Up to 2 years of age	Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires
Frequency of vegetable consumption (times/day) at age 1 year	1 year of age	Measured at 1 year using a food frequency questionnaire
Breastfeeding initiation rate	Up to 2 years of age	Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires
Predominant and any breastfeeding durations	Up to 2 years of age	Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires
Dietary patterns at age 1 year	1 year of age	Measured at 1 year using a food frequency questionnaire
Lifestyle patterns at age 1 year	1 year of age	Measured at 1 year using dietary variables from the food frequency questionnaire; and movement behavioral variables (physical activity and sedentary behaviors) measured with a questionnaire. Lifestyle patterns will be derived using principal component analysis
Weight growth curves from birth to 2 y	Up to 2 years of age	Weight measured at different time points from birth to 2 y
Proportion of children that are overweight or obese at age 2 years	2 years of age	Weight, length and BMI measured at different time points from birth to 2 y
Lifestyle patterns at age 2 years	2 years of age	Measured at 2 years using dietary variables from the food frequency questionnaire; and movement behavioral variables (physical activity and sedentary behaviors) measured with a questionnaire. Lifestyle patterns will be derived using principal component analysis
Length growth curves from birth to 2 y	Up to 2 years of age	Length measured at different time points from birth to 2 y

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Lille, France

Valenciennes Hospital, Monaco Hospital maternity; 🇫🇷 Valenciennes, France