Clinical trial NCT05285761: feediNg gUidelines infanT RandomIzEd coNtrolled Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: Complementary feeding
Delivery of information
Recommendations
BMI z-score
Parental feeding practices
Infant eating behavior
Smartphone application
RCT
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Institut de Recherche en Santé Publique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Burgundy
First posted: 2022-03-18
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention run between 3 and 36 months of the children, randomisation of children within a control (n=165) or intervention group (n=165).
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Body mass index z-score at the age of 36 months
timeFrame: End of intervention (at the age of 36 months)
Secondary outcomes:
measure: Body mass index z-score at the age of 48 months
timeFrame: Follow-up (at the age of 48 months)
measure: Children's eating behaviour (self-reported by parents)
timeFrame: at the ages of 12 and 36 months
measure: Infant appetite control abilities (self-reported by parents)
timeFrame: at the ages of 12 and 36 months
measure: Infant appetite control abilities (behavioral observation)
timeFrame: at the age of 11 months
measure: Infant appetite control abilities (behavioral observation)
timeFrame: at the age of 30 months
measure: Parental feeding practices (self-reported by parents)
timeFrame: at the ages of 12, 24, 36 months
measure: Parental feeding practices (behavioral observation)
timeFrame: at the ages of 32 and 36 months
measure: Introduction of complementary foods
timeFrame: at the ages of 3, 6, 12, 18, 24, 36, 48 months
measure: Food frequency and food acceptance
timeFrame: at the age of 36 months
measure: Food texture exposure and acceptance
timeFrame: at the age of 12 months
measure: Child feeding skills
timeFrame: at the ages of 12 and 36 months
measure: Meal context - FPSQ
timeFrame: at the ages of 12, 24, 36 months
measure: Meal context - FFBS
timeFrame: at the ages of 12, 24, 36 months
measure: Maternal distractions during feeding - Use of technological distractors
timeFrame: at the ages of 12, 24, 36 months
measure: Maternal distractions during feeding - Perceived Distraction
timeFrame: at the ages of 12, 24, 36 months
measure: Knowledge about infant nutrition
timeFrame: at the age of 36 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre des Sciences du Goût et de l'Alimentation
Study officials:
affiliation: INRAE UMR CSGA
name: Camille Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
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