Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2022-03-24
2027-03-31
Brief Summary
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Detailed Description
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In France, new recommendations relating to complementary feeding are disseminated to the general public by Santé publique France (the French Public Health Agency) since September 2021 in the form of a paper brochure. Based on the recommendations of this brochure, a smartphone application was developped.
Parents in the intervention (n=165) and control groups (n=165) will receive the paper brochure when the infant will reach the age of 3 months. In the intervention group, a smartphone application will additionnaly support this paper medium, providing information and very short videos illustrating some aspects of responsive feeding during complementary feeding and taking up the themes of the paper brochure. Information will be sent through the smartphone app regularly until the children reach the age of 36 months. In total 106 specific messages will be sent to parents between 3 and 36 months in the intervention group and 48 generic messages to both groups.
The main objective is to determine if the intervention is associated to a difference between the BMI z-score at the age of 36 months of the children of the parents of the intervention group, compared with those of the control group. Parental feeding practices and infant eating behavior will be evaluated several times during the follow-up from the 3rd month of the infant until his 48th month with various validated questionnaires from the literature (n=330) and with behavioral evaluations (n=130, 65 in each group) carried out during meals filmed in the laboratory and at the participants' homes.
Our goal is to involve a total of 330 parents and children (with only first-time parents); the first 30 children will allow us to test the device but their data may not be included in the final analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Parents are randomized into 2 groups (intervention vs. control) via the smartphone application. The investigators conduct the study without information on group allocation. The investigators will analyse the data without information on group allocation.
Study Groups
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paper brochure + smartphone application
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. They will also receive the new recommendations relating to complementary feeding through an educational device in the form of a smartphone application. This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd month until the 36th month of the child. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.
Provision of extended information on the conduct of complementary feeding
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.
In addition to the paper brochure and the generic information, parents in the intervention group will also receive the new recommendations relating to CF through an educational device (in the form of a smartphone application). This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd months until the 36th months of the child.
paper brochure
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.
Provision of current official information on complementary feeding
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.
Interventions
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Provision of extended information on the conduct of complementary feeding
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.
In addition to the paper brochure and the generic information, parents in the intervention group will also receive the new recommendations relating to CF through an educational device (in the form of a smartphone application). This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd months until the 36th months of the child.
Provision of current official information on complementary feeding
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.
Eligibility Criteria
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Inclusion Criteria
* child age is between 1 and 54 days
* parents living in Dijon and its surroundings (\~ 70 km around Dijon)
* parents who master enough the french language to understand and answer self-reported questionnaires
Exclusion Criteria
* parents of a child born before 31 weeks of amenorrhea
* parents of a child presenting since birth with pathologies likely to have a strong impact on his diet or his feeding habits (allergy to cow's milk proteins, feeding through a nasogastric tube or gastrostomy, congenital defect of the digestive tract, oral feeding disorders)
* parents of a child with a multiple pregnancy (≥ 3 children).
* in the event of a twin birth, the follow-up for this study only focuses on one of the children (according to a random draw)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Institut de Recherche en Santé Publique, France
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University of Burgundy
OTHER
Centre des Sciences du Goût et de l'Alimentation
OTHER
Responsible Party
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Principal Investigators
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Camille Schwartz, PhD
Role: PRINCIPAL_INVESTIGATOR
INRAE UMR CSGA
Locations
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Centre des Sciences du Goût et de l'Alimentation
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Loïc Briand, CSGA head
Role: primary
References
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Asta K, Miller AL, Retzloff L, Rosenblum K, Kaciroti NA, Lumeng JC. Eating in the Absence of Hunger and Weight Gain in Low-income Toddlers. Pediatrics. 2016 May;137(5):e20153786. doi: 10.1542/peds.2015-3786. Epub 2016 Apr 18.
Brugailleres P, Chabanet C, Issanchou S, Schwartz C. Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits. Appetite. 2019 Nov 1;142:104382. doi: 10.1016/j.appet.2019.104382. Epub 2019 Jul 23.
Brugailleres P, Issanchou S, Nicklaus S, Chabanet C, Schwartz C. Caloric compensation in infants: developmental changes around the age of 1 year and associations with anthropometric measurements up to 2 years. Am J Clin Nutr. 2019 May 1;109(5):1344-1352. doi: 10.1093/ajcn/nqy357.
de Lauzon-Guillain B, Musher-Eizenman D, Leporc E, Holub S, Charles MA. Parental feeding practices in the United States and in France: relationships with child's characteristics and parent's eating behavior. J Am Diet Assoc. 2009 Jun;109(6):1064-9. doi: 10.1016/j.jada.2009.03.008.
Jansen E, Williams KE, Mallan KM, Nicholson JM, Daniels LA. The Feeding Practices and Structure Questionnaire (FPSQ-28): A parsimonious version validated for longitudinal use from 2 to 5 years. Appetite. 2016 May 1;100:172-80. doi: 10.1016/j.appet.2016.02.031. Epub 2016 Feb 18.
McCurdy K, Gorman KS. Measuring family food environments in diverse families with young children. Appetite. 2010 Jun;54(3):615-8. doi: 10.1016/j.appet.2010.03.004. Epub 2010 Mar 20.
Monnery-Patris S, Rigal N, Peteuil A, Chabanet C, Issanchou S. Development of a new questionnaire to assess the links between children's self-regulation of eating and related parental feeding practices. Appetite. 2019 Jul 1;138:174-183. doi: 10.1016/j.appet.2019.03.029. Epub 2019 Mar 26.
Musher-Eizenman D, Holub S. Comprehensive Feeding Practices Questionnaire: validation of a new measure of parental feeding practices. J Pediatr Psychol. 2007 Sep;32(8):960-72. doi: 10.1093/jpepsy/jsm037. Epub 2007 May 28.
Sall NS, Begin F, Dupuis JB, Bourque J, Menasria L, Main B, Vong L, Hun V, Raminashvili D, Chea C, Chiasson L, Blaney S. A measurement scale to assess responsive feeding among Cambodian young children. Matern Child Nutr. 2020 Jul;16(3):e12956. doi: 10.1111/mcn.12956. Epub 2020 Jan 30.
Tournier C, Demonteil L, Ksiazek E, Marduel A, Weenen H, Nicklaus S. Factors Associated With Food Texture Acceptance in 4- to 36-Month-Old French Children: Findings From a Survey Study. Front Nutr. 2021 Feb 1;7:616484. doi: 10.3389/fnut.2020.616484. eCollection 2020.
van der Veek SMC, de Graaf C, de Vries JHM, Jager G, Vereijken CMJL, Weenen H, van Winden N, van Vliet MS, Schultink JM, de Wild VWT, Janssen S, Mesman J. Baby's first bites: a randomized controlled trial to assess the effects of vegetable-exposure and sensitive feeding on vegetable acceptance, eating behavior and weight gain in infants and toddlers. BMC Pediatr. 2019 Aug 1;19(1):266. doi: 10.1186/s12887-019-1627-z.
Ventura AK, Hupp M, Alvarez Gutierrez S, Almeida R. Development and validation of the Maternal Distraction Questionnaire. Heliyon. 2020 Feb 1;6(2):e03276. doi: 10.1016/j.heliyon.2020.e03276. eCollection 2020 Feb.
Riera-Navarro C, Schwartz C, Ducrot P, Noirot L, Delamaire C, Sales-Wuillemin E, Semama DS, Lioret S, Nicklaus S. A web-based and mobile randomised controlled trial providing complementary feeding guidelines to first-time parents in France to promote responsive parental feeding practices, healthy children's eating behaviour and optimal body mass index: the NutrienT trial study protocol. BMC Public Health. 2024 Sep 27;24(1):2649. doi: 10.1186/s12889-024-20057-z.
Other Identifiers
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2020-A01941-38
Identifier Type: -
Identifier Source: org_study_id
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