The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL) (ECAIL)
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| ClinicalTrials.gov Identifier: NCT03003117 |
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Recruitment Status :
Recruiting
First Posted : December 26, 2016
Last Update Posted : June 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diet Growth Infant Physical Activity Sedentary Behavior | Behavioral: Experimental: Intervention Program Behavioral: Active comparator: Usual Care | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| 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) |
| Actual Study Start Date : | April 3, 2017 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Program
Experimental: Intervention Program
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Behavioral: Experimental: Intervention Program
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. |
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Active Comparator: Usual Care
Active comparator: Usual Care
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Behavioral: Active comparator: Usual Care
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. |
- 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
- Breastfeeding initiation rate [ Time Frame: 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 [ Time Frame: 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
- Age at complementary feeding introduction [ Time Frame: 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
- Age at first introduction of processed (but not baby-specific) foods [ Time Frame: 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 [ Time Frame: 1 year of age ]Measured at 1 year using a food frequency questionnaire
- Dietary patterns at age 1 year [ Time Frame: 1 year of age ]Measured at 1 year using a food frequency questionnaire
- Lifestyle patterns at age 1 year [ Time Frame: 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 velocity over the six first months of life [ Time Frame: Up to 6 months of age ]Weight measured at different time points from birth to 6 months of age
- BMI at age 2 years [ Time Frame: 2 years of age ]Weight, length and BMI measured at different time points from birth to 2 y
- Proportion of children that are overweight or obese at age 2 years [ Time Frame: 2 years of age ]Weight, length and BMI measured at different time points from birth to 2 y
- Dietary patterns at age 2 years [ Time Frame: 2 years of age ]Measured at 2 years using a food frequency questionnaire
- Lifestyle patterns at age 2 years [ Time Frame: 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
- Weight growth curves from birth to 2 y [ Time Frame: Up to 2 years of age ]Weight measured at different time points from birth to 2 y
- Length growth curves from birth to 2 y [ Time Frame: Up to 2 years of age ]Length measured at different time points from birth to 2 y
- BMI curves from birth to 2 y [ Time Frame: Up to 2 years of age ]BMI measured at different time points from birth to 2 y
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003117
| Contact: Sandrine Lioret, PhD | 00 33 1 45 59 51 78 | sandrine.lioret@inserm.fr | |
| Contact: Blandine de Lauzon-Guillain, PhD | 00 33 1 45 59 50 19 | blandine.delauzon@inserm.fr |
| France | |
| University Hospital | Recruiting |
| Lille, France, 59037 | |
| Contact: Dominique Turck, MD, PhD 00 33 3 20 44 68 85 Dominique.TURCK@chru-lille.fr | |
| Contact: Laurent Béghin, PhD 00 33 3 20 44 60 58 Laurent.BEGHIN@chru-lille.fr | |
| Valenciennes Hospital, Monaco Hospital maternity | Recruiting |
| Valenciennes, France, 59300 | |
| Contact: Pauline Devouge, Dr devouge-p@ch-valenciennes.fr | |
| Contact: Aurore Dehon dehon-a@ch-valenciennes.fr | |
| Principal Investigator: | Sandrine Lioret, PhD | Institut National de la Santé Et de la Recherche Médicale, France | |
| Principal Investigator: | Dominique Turck, MD, PhD | University Hospital, Lille |
| Responsible Party: | Sandrine LIORET, Senior Research Fellow, PhD, Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT03003117 |
| Other Study ID Numbers: |
2014-A00849-38 n°CPP 03/010/2014 ( Other Identifier: Comité de Protection des Personnes Nord-Ouest 1 ) |
| First Posted: | December 26, 2016 Key Record Dates |
| Last Update Posted: | June 21, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infant Diet Growth Breastfeeding Complementary feeding Pregnancy Body mass index |
Social disadvantage Randomized controlled trial Education Food vouchers Physical activity Screen |