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The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL) (ECAIL)

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ClinicalTrials.gov Identifier: NCT03003117
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Lille
Association Programme MALIN
Société Française de Pédiatrie
Bledina
Information provided by (Responsible Party):
Sandrine LIORET, Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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 and growth in young children.

Condition or disease Intervention/treatment Phase
Diet Growth Infant Behavioral: Experimental: Intervention Program Behavioral: Active comparator: Usual Care Not Applicable

Detailed Description:
This randomized controlled trial will test an early home based multi-component intervention program designed to promote healthy feeding practices and diet 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), 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 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 and baby 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 diet and growth in the first 2 years of life.

Study Design
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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 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 : December 2022
Estimated Study Completion Date : July 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Program
Experimental: Intervention Program
 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), consistent with the French Nutrition and Health Program (PNNS) guidelines (component 1). Fresh fruit and vegetable baskets 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 and baby 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 Care
Active comparator: Usual Care
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Dietary patterns at age 1 year [ Time Frame: 1 year of age ]
    Measured at 1 year using a food frequency questionnaire

  7. 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

  8. 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

  9. 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

  10. Dietary patterns at age 2 years [ Time Frame: 2 years of age ]
    Measured at 2 years using a food frequency questionnaire

  11. 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

  12. 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

  13. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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

Locations
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   
Sponsors and Collaborators
French Red Cross
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Lille
Association Programme MALIN
Société Française de Pédiatrie
Bledina
Investigators
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
More Information
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Responsible Party: Sandrine LIORET, Senior Research Fellow, PhD, Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03003117     History of Changes
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: November 15, 2018
Last Verified: November 2018
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

Keywords provided by Sandrine LIORET, Institut National de la Santé Et de la Recherche Médicale, France:
Infant
Diet
Growth
Breastfeeding
Complementary feeding
Pregnancy
 Body mass index
Social disadvantage
Randomized controlled trial
Education
Food vouchers