- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003117
The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL) (ECAIL)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandrine Lioret, PhD
- Phone Number: 00 33 1 45 59 51 78
- Email: sandrine.lioret@inserm.fr
Study Contact Backup
- Name: Blandine de Lauzon-Guillain, PhD
- Phone Number: 00 33 1 45 59 50 19
- Email: blandine.delauzon@inserm.fr
Study Locations
-
-
-
Lille, France, 59037
- Completed
- University Hospital
-
Valenciennes, France, 59300
- Recruiting
- Valenciennes Hospital, Monaco Hospital maternity
-
Contact:
- Pauline Devouge, Dr
- Email: devouge-p@ch-valenciennes.fr
-
Contact:
- Aurore Dehon
- Email: dehon-a@ch-valenciennes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Program
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. |
Active Comparator: Usual Care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 2 years of age
|
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
|
Up to 2 years of age
|
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
|
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
|
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
|
Up to 2 years of age
|
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
|
1 year of age
|
Dietary patterns at age 1 year
Time Frame: 1 year of age
|
Measured at 1 year using a food frequency questionnaire
|
1 year of age
|
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
|
1 year of age
|
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
|
Up 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
|
2 years of age
|
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
|
2 years of age
|
Dietary patterns at age 2 years
Time Frame: 2 years of age
|
Measured at 2 years using a food frequency questionnaire
|
2 years of age
|
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
|
2 years of age
|
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
|
Up to 2 years of age
|
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
|
Up to 2 years of age
|
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
|
Up to 2 years of age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandrine Lioret, PhD, Institut National de la Santé Et de la Recherche Médicale, France
- Principal Investigator: Delphine Ley, MD, PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014-A00849-38
- n°CPP 03/010/2014 (Other Identifier: Comité de Protection des Personnes Nord-Ouest 1)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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