feediNg gUidelines infanT RandomIzEd coNtrolled Trial (NUTRIENT)

Centre des Sciences du Goût et de l'Alimentation

Status: Enrolling

Conditions: Healthy Volunteers

Treatments: Behavioral: Provision of current official information on complementary feeding; Behavioral: Provision of extended information on the conduct of complementary feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT05285761

2020-A01941-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

330 participants in 2 patient groups

paper brochure + smartphone application

Experimental group

Description:

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.

Treatment:

Behavioral: Provision of extended information on the conduct of complementary feeding

paper brochure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Provision of current official information on complementary feeding