feediNg gUidelines infanT RandomIzEd coNtrolled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Provision of extended information on the conduct of complementary feeding

    Behavioral

    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

    Behavioral

    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.

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: paper brochure + smartphone applicationExperimental treatment 1 intervention
Group B: paper brochureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body mass index z-score at the age of 36 months

Z-score of the body mass index (BMI, kg / m²) at the age of 36 months of the child of the parents included in the study, calculated from measurements of the child's weight and height at the age of 36 months (carried out in the laboratory) and according to the WHO references.

Time frame
End of intervention (at the age of 36 months)

Secondary outcomes

1

Body mass index z-score at the age of 48 months

Z-score of the body mass index (BMI, kg / m²), calculated from measurements of the child's weight and height at the age of 48 months (parent-reports of the measurements contained in the child health record) and according to the WHO references.

Time frame
Follow-up (at the age of 48 months)
2

Children's eating behaviour (self-reported by parents)

Parent-reports using the french version of the Child Eating Behaviour Questionnaire adapted for toddlers (CEBQ-T) which is a validated questionnaire. The questionnaire is composed of 31 items. Parent answers to each item using a 6-category scale (never, rarely, sometimes, often, always, I don't know). The items are then grouped to define 7 dimensions : 'food responsiveness', 'enjoyment of food', 'satiety responsiveness', 'food fussiness', 'slowness in eating', 'emotional overeating', and 'external food cue responsiveness'. Higher scores mean higher behaviours.

Time frame
at the ages of 12 and 36 months
3

Infant appetite control abilities (self-reported by parents)

Parent-reports at the ages of 12 and 36 months using a validated questionnaire. Parent answers to 9 items, which are then grouped to define 2 dimensions: 'Caloric compensation' and 'Eating in the absence of hunger' (EAH). Parent answers to items using a 5-category scale (never, rarely, sometimes, often, always). Higher scores mean higher behaviours.

Time frame
at the ages of 12 and 36 months
4

Infant appetite control abilities (behavioral observation)

Infant caloric compensation ability during 2 meals at the laboratory at the age of 11 months (calculation of "COMPX" scores)

Time frame
at the age of 11 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Lead sponsor

Centre Hospitalier Universitaire Dijon

Collaborator

Institut de Recherche en Santé Publique, France

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

University of Burgundy

Collaborator