DietECAILNCT03003117
The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)
A study testing Experimental: Intervention Program in people with Diet and Growth, run by French Red Cross at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Experimental: Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Apr 2017to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Lille, 59037
Valenciennes Hospital, Monaco Hospital maternity
Valenciennes, 59300
About this study
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)
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.
Read the 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.
- Conditions
- Diet, Growth, Infant, Physical Activity, Sedentary Behavior
- Being tested
- Experimental: Intervention Program, Active comparator: Usual Care
- Keywords
- Infant, Diet, Growth, Breastfeeding, Complementary feeding, Pregnancy, Body mass index, Social disadvantage, Randomized controlled trial, Education, Food vouchers, Physical activity, Screen
- Medical subject headings
- Motor Activity, Sedentary Behavior, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention ProgramBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program | Experimental | Experimental: Intervention Program Receives: Behavioral: Experimental: Intervention Program |
| Usual Care | Active comparator | Active comparator: Usual Care Receives: Behavioral: Active comparator: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vegetable consumption (times/day) at age 2 years
Measured at 2 years using a food frequency questionnaire
Measured: 2 years of age
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year of age
Dietary patterns at age 1 year
Measured at 1 year using a food frequency questionnaire
Measured: 1 year of age
Lifestyle patterns at age 1 year
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
Measured: 1 year of age
Weight growth velocity over the six first months of life
Weight measured at different time points from birth to 6 months of age
Measured: Up to 6 months of age
BMI at age 2 years
Weight, length and BMI measured at different time points from birth to 2 y
Measured: 2 years of age
Proportion of children that are overweight or obese at age 2 years
Weight, length and BMI measured at different time points from birth to 2 y
Measured: 2 years of age
Dietary patterns at age 2 years
Measured at 2 years using a food frequency questionnaire
Measured: 2 years of age
Lifestyle patterns at age 2 years
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
Measured: 2 years of age
Weight growth curves from birth to 2 y
Weight measured at different time points from birth to 2 y
Measured: Up to 2 years of age
Length growth curves from birth to 2 y
Length measured at different time points from birth to 2 y
Measured: Up to 2 years of age
BMI curves from birth to 2 y
BMI measured at different time points from birth to 2 y
Measured: Up to 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start3 Apr 2017
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Red Cross
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Lille, Association Programme MALIN, Société Française de Pédiatrie, Association Française de Pédiatrie Ambulatoire
- Responsible party
- Principal investigator, Sandrine LIORET, Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- Sandrine Lioret, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceDelphine Ley, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003117
- Sponsor's protocol ID
- 2014-A00849-38
- Other IDs
- n°CPP 03/010/2014
- Acronym
- ECAIL
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poquet D, Le Gal C, Hincker P, Beghin L, Deplanque D, Subtil D, Sion O, Cavalli B, Vanhoutte L, Jacobsen V, Marr K, Sakellaris I, de Lauzon Guillain B, Charles MA, Ley D, Sauvegrain P, Lioret S. Reach and engagement in the ECAIL trial targeting socially disadvantaged families across the COVID-19 pandemic and cost-of-living crisis: A mixed-methods implementation study. PLoS One. 2026 Oct 8;21(10):e0350372. doi: 10.1371/journal.pone.0350372. eCollection 2026.
PubMed 42848780Poquet D, de Lauzon-Guillain B, Ley D, Charles MA, Sauvegrain P, Lioret S. Intentions, practices, and social representations regarding breastfeeding among women experiencing social disadvantage: findings from the qualitative component of the ECAIL trial. Int Breastfeed J. 2026 Jan 23;21(1):22. doi: 10.1186/s13006-026-00812-1.
PubMed 41578315Lioret S, Sion O, Hincker P, Beghin L, de Lauzon-Guillain B, Cavalli B, Salinier C, Turck D, Perez N, Subtil D, Brun S, Charlier M, Creps E, Dehon A, Le Gal C, Poquet D, Sauvegrain P, Heude B, Deplanque D, Meyran D, Devouge P, Ley D, Charles MA. Home visiting intervention over pregnancy and the first two years of life to promote healthy feeding practices and energy balance-related behaviors and prevent obesity risk in children from socially disadvantaged families: protocol for a participant-blinded, two-arm, parallel-group randomized controlled trial-the ECAIL study. BMC Public Health. 2025 Oct 29;25(1):3659. doi: 10.1186/s12889-025-25004-0.
PubMed 41162889
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03003117
- Acronym / sponsor ID
- ECAIL / 2014-A00849-38
- Conditions
- Diet, Growth, Infant, Physical Activity, Sedentary Behavior
- Keywords
- Infant, Diet, Growth, Breastfeeding, Complementary feeding, Pregnancy, Body mass index, Social disadvantage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- French Red CrossUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Lille, Association Programme MALIN, Société Française de Pédiatrie, Association Française de Pédiatrie Ambulatoire
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Experimental: Intervention ProgramExperimental: Intervention Program |
| Usual Care | Active comparator | Behavioral: Active comparator: Usual CareActive comparator: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention ProgramThe 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. | Behavioural | Intervention Program |
| Active comparator: Usual CareUsual 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. | Behavioural | Usual Care |
Primary outcome
Frequency of vegetable consumption (times/day) at age 2 years
Time frame: 2 years of age
Measured at 2 years using a food frequency questionnaire
15 secondary outcomes
Breastfeeding initiation rate
Time frame: Up to 2 years of age
Predominant and any breastfeeding durations
Time frame: Up to 2 years of age
Age at complementary feeding introduction
Time frame: Up to 2 years of age
Age at first introduction of processed (but not baby-specific) foods
Time frame: Up to 2 years of age
Frequency of vegetable consumption (times/day) at age 1 year
Time frame: 1 year of age
Dietary patterns at age 1 year
Time frame: 1 year of age
Lifestyle patterns at age 1 year
Time frame: 1 year of age
Weight growth velocity over the six first months of life
Time frame: Up to 6 months of age
BMI at age 2 years
Time frame: 2 years of age
Proportion of children that are overweight or obese at age 2 years
Time frame: 2 years of age
Dietary patterns at age 2 years
Time frame: 2 years of age
Lifestyle patterns at age 2 years
Time frame: 2 years of age
Weight growth curves from birth to 2 y
Time frame: Up to 2 years of age
Length growth curves from birth to 2 y
Time frame: Up to 2 years of age
BMI curves from birth to 2 y
Time frame: Up to 2 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42848780Poquet D, Le Gal C, Hincker P, Beghin L, Deplanque D, Subtil D, Sion O, Cavalli B, Vanhoutte L, Jacobsen V, Marr K, Sakellaris I, de Lauzon Guillain B, Charles MA, Ley D, Sauvegrain P, Lioret S. Reach and engagement in the ECAIL trial targeting socially disadvantaged families across the COVID-19 pandemic and cost-of-living crisis: A mixed-methods implementation study. PLoS One. 2026 Oct 8;21(10):e0350372. doi: 10.1371/journal.pone.0350372. eCollection 2026.
- Derived from this study: PubMed 41578315Poquet D, de Lauzon-Guillain B, Ley D, Charles MA, Sauvegrain P, Lioret S. Intentions, practices, and social representations regarding breastfeeding among women experiencing social disadvantage: findings from the qualitative component of the ECAIL trial. Int Breastfeed J. 2026 Jan 23;21(1):22. doi: 10.1186/s13006-026-00812-1.
- Derived from this study: PubMed 41162889Lioret S, Sion O, Hincker P, Beghin L, de Lauzon-Guillain B, Cavalli B, Salinier C, Turck D, Perez N, Subtil D, Brun S, Charlier M, Creps E, Dehon A, Le Gal C, Poquet D, Sauvegrain P, Heude B, Deplanque D, Meyran D, Devouge P, Ley D, Charles MA. Home visiting intervention over pregnancy and the first two years of life to promote healthy feeding practices and energy balance-related behaviors and prevent obesity risk in children from socially disadvantaged families: protocol for a participant-blinded, two-arm, parallel-group randomized controlled trial-the ECAIL study. BMC Public Health. 2025 Oct 29;25(1):3659. doi: 10.1186/s12889-025-25004-0.
- Individual participant dataSharing planned: No
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Lioret, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Delphine Ley, MD, PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention Program in people with Diet and Growth, run by French Red Cross at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vegetable consumption (times/day) at age 2 years (time frame: 2 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.