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Recruiting NCT05285761

feediNg gUidelines infanT RandomIzEd coNtrolled Trial

No phase Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Provision of extended information on the conduct of complementary feeding, Provision of current official information on complementary feeding.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ECR Visant à évaluer l'Effet d'Une Intervention Sur la Diffusion d'Informations (Conduite de la Diversification Alimentaire) Sur le Comportement de Nourrissage Des Parents, le Comportement Alimentaire et le Statut pondéral de l'Enfant

Overview

The purpose of this randomized controlled trial is to conduct an intervention aimed at providing first-time parents with information on the conduct of complementary feeding through a paper brochure and a smartphone application, to test the effect of this intervention (compared to usual care, i.e. receiving the paper brochure only), on infant corpulence at 36 and 48 months of age, and parental feeding practices and infant eating behavior up to 36 months of age.

Detailed description

The intervention will consist in the dissemination of new French recommendations relating to complementary feeding, in particular in connection with an educational device in the form of a smartphone application delivering relevant infant feeding messages in due time between the ages of 3 and 36 months.

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.

Interventions

  • Behavioral 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 bro
  • Behavioral 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.

Primary outcome measures

  • Body mass index z-score at the age of 36 months [Time frame: End of intervention (at the age of 36 months)]
Secondary outcome measures (12)
  • Body mass index z-score at the age of 48 months [Time frame: Follow-up (at the age of 48 months)]
  • Children's eating behaviour (self-reported by parents) [Time frame: at the ages of 12 and 36 months]
  • Infant appetite control abilities (self-reported by parents) [Time frame: at the ages of 12 and 36 months]
  • Infant appetite control abilities (behavioral observation) [Time frame: at the age of 11 months]
  • Infant appetite control abilities (behavioral observation) [Time frame: at the age of 30 months]
  • Parental feeding practices (self-reported by parents) [Time frame: at the ages of 12, 24, 36 months]
  • Parental feeding practices (behavioral observation) [Time frame: at the ages of 32 and 36 months]
  • Introduction of complementary foods [Time frame: at the ages of 3, 6, 12, 18, 24, 36, 48 months]
  • Food frequency and food acceptance [Time frame: at the age of 36 months]
  • Food texture exposure and acceptance [Time frame: at the age of 12 months]
  • Child feeding skills [Time frame: at the ages of 12 and 36 months]
  • Meal context - FPSQ [Time frame: at the ages of 12, 24, 36 months]

Eligibility criteria

Inclusion criteria

  • first-time parents
  • 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

  • no affiliation to a social security scheme
  • 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)
  • additional exclusion criteria for participation in filmed meals from the age of 11 months: children with food allergies or intolerances or suffering from celiac disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

France · 1 center
  • Centre des Sciences du Goût et de l'Alimentation — Dijon

Publications

  • 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. PMID 27244808
  • 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. PMID 31348973
  • 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. PMID 30997507
  • 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. PMID 19465189
  • 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. PMID 26911263
  • 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. PMID 20227449
  • 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. PMID 30926418
  • 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. PMID 17535817

Identifiers

NCT: NCT05285761 · 2020-A01941-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗