Clinical trial NCT03003117: The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)
Official title: Effectiveness of an Early Intervention Aiming at Promoting Healthy Diet, Lifestyle and Growth of Children Living in Situation of Social Disadvantage : the prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: French Red Cross
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Hospital, Lille
name: Association Programme MALIN
name: Société Française de Pédiatrie
name: Association Française de Pédiatrie Ambulatoire
First posted: 2016-12-26
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Frequency of vegetable consumption (times/day) at age 2 years
timeFrame: 2 years of age
Secondary outcomes:
measure: Breastfeeding initiation rate
timeFrame: Up to 2 years of age
measure: Predominant and any breastfeeding durations
timeFrame: Up to 2 years of age
measure: Age at complementary feeding introduction
timeFrame: Up to 2 years of age
measure: Age at first introduction of processed (but not baby-specific) foods
timeFrame: Up to 2 years of age
measure: Frequency of vegetable consumption (times/day) at age 1 year
timeFrame: 1 year of age
measure: Dietary patterns at age 1 year
timeFrame: 1 year of age
measure: Lifestyle patterns at age 1 year
timeFrame: 1 year of age
measure: Weight growth velocity over the six first months of life
timeFrame: Up to 6 months of age
measure: BMI at age 2 years
timeFrame: 2 years of age
measure: Proportion of children that are overweight or obese at age 2 years
timeFrame: 2 years of age
measure: Dietary patterns at age 2 years
timeFrame: 2 years of age
measure: Lifestyle patterns at age 2 years
timeFrame: 2 years of age
measure: Weight growth curves from birth to 2 y
timeFrame: Up to 2 years of age
measure: Length growth curves from birth to 2 y
timeFrame: Up to 2 years of age
measure: BMI curves from birth to 2 y
timeFrame: Up to 2 years of age
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital
city: Valenciennes
country: France
facility: Valenciennes Hospital, Monaco Hospital maternity
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Sandrine Lioret, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Delphine Ley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: