The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

French Red Cross

Status: Active, not recruiting

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

Treatments: Behavioral: Active comparator: Usual Care; Behavioral: Experimental: Intervention Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03003117

n°CPP 03/010/2014 (Other Identifier)

2014-A00849-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

800 participants in 2 patient groups

Intervention Program

Experimental group

Description:

Experimental: Intervention Program

Treatment:

Behavioral: Experimental: Intervention Program

Usual Care

Active Comparator group

Description:

Active comparator: Usual Care

Treatment:

Behavioral: Active comparator: Usual Care