feediNg gUidelines infanT RandomIzEd coNtrolled Trial

NCT05285761 | Recruiting

• 1 other identifier: 2020-A01941-38
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Complementary feeding; Delivery of information; Recommendations; BMI z-score; Parental feeding practices; Infant eating behavior; Smartphone application; RCT

Outcome Measures

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.

  End of intervention (at the age of 36 months)

Secondary Outcomes (16)

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

  Follow-up (at the age of 48 months)

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

  at the ages of 12 and 36 months

• Infant appetite control abilities (self-reported by parents)

  at the ages of 12 and 36 months

• Infant appetite control abilities (behavioral observation)

  at the age of 11 months

• Infant appetite control abilities (behavioral observation)

  at the age of 30 months

Study Arms (2)

paper brochure + smartphone application

EXPERIMENTAL

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.

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

paper brochure

ACTIVE COMPARATOR

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.

Behavioral: Provision of current official information on complementary feeding

Interventions

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.

paper brochure + smartphone application

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.

paper brochure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre des Sciences du Goût et de l'Alimentation

Dijon, 21000, France

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31999399 BACKGROUND

• 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.

  PMID: 33598476 BACKGROUND

• 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.

  PMID: 31370830 BACKGROUND

• 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.

  PMID: 32025583 BACKGROUND

• 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.

  PMID: 39334106 DERIVED

Study Officials

• Camille Schwartz, PhD

  INRAE UMR CSGA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Schwartz, PhD

CONTACT

00 333 80 69 37 43; camille.schwartz@inrae.fr

Sophie Nicklaus, PhD

CONTACT

00 333 80 69 35 18; sophie.nicklaus@inrae.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parents are informed that the aim of the study concerns the effect of the dissemination of information relating to the conduct of complementary feeding on parental feeding behavior during meals as well as on the eating behavior of their child, but they are blinded to the group (intervention vs. control) to which they are allocated. 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention run between 3 and 36 months of the children, randomisation of children within a control (n=165) or intervention group (n=165).

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 18, 2022
• Study Start: March 24, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: March 2025
• Access Criteria: Public

Locations

FR (1)