The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

N/AActive Not RecruitingNCT03003117

French Red Cross800 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

800

Conditions

Diet Growth Infant Physical Activity Sedentary Behavior

Interventions

Experimental: Intervention ProgramBEHAVIORAL

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 CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (2)

University Hospital

Lille, France

Valenciennes Hospital, Monaco Hospital maternity

Valenciennes, France

Outcomes

Primary Outcomes

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

Measured at 2 years using a food frequency questionnaire

Time frame: 2 years of age

Secondary Outcomes

Breastfeeding initiation rate

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

Time frame: Up to 2 years of age

Predominant and any breastfeeding durations

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

Time frame: Up to 2 years of age

Age at complementary feeding introduction

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

Time frame: Up to 2 years of age

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

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

Time frame: Up to 2 years of age

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

Measured at 1 year using a food frequency questionnaire

Time frame: 1 year of age

Dietary patterns at age 1 year

Measured at 1 year using a food frequency questionnaire

Data from ClinicalTrials.gov

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