AzTrials
AzTrials

Healthy VolunteersNUTRIENTNCT05285761

feediNg gUidelines infanT RandomIzEd coNtrolled Trial

A study testing Provision of extended information on the conduct of complementary feeding and Provision of current official information on complementary feeding in people with Healthy Volunteers, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Provision of extended information on the conduct of complementary feeding and Provision of current official information on complementary feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteFrance
Study dates
24 Mar 2022to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

France1 site, 1 recruiting
  • Centre des Sciences du Goût et de l'Alimentation

    Dijon, 21000

    Loïc Briand, CSGA head

    Camille Schwartz, PhD

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Provision of extended information on the conduct of complementary feeding, Provision of current official information on complementary feeding
Keywords
Complementary feeding, Delivery of information, Recommendations, BMI z-score, Parental feeding practices, Infant eating behavior, Smartphone application, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provision of extended information on the conduct of complementary feedingBehavioural

    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 feedingBehavioural

    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.

Study groups in NCT05285761
Study groupRoleWhat they receive
paper brochure + smartphone applicationExperimentalParents 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.
Receives: Behavioral: Provision of extended information on the conduct of complementary feeding
paper brochureActive comparatorParents 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.
Receives: Behavioral: Provision of current official information on complementary feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: End of intervention (at the age of 36 months)

Secondary outcomes (16)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: at the age of 11 months

  5. Infant appetite control abilities (behavioral observation)

    Infant Eating in the Absence of Hunger (EAH) during a meal at the laboratory at the age of 30 months (assessment of quantities and choice of food consumed during 10 minutes after a meal, i.e. when the child is no longer hungry).

    Measured: at the age of 30 months

  6. Parental feeding practices (self-reported by parents)

    Parent-reports at the ages of 12, 24, 36 months using the validated French version of the Child Feeding Practices Questionnaire. Parent answers to items 1-12 using a 6-category scale (never, rarely, sometimes, often, always, not concerned). Parent answers to items 13-39 using a 5-category scale (not at all true, bit true, moderately true, rather true, very true). The 39 items are grouped to define 10 dimensions: 'Monitoring' , 'Child control' , 'Emotion Regulation' 'Positive habits', 'Restriction for weight control', 'Restriction for health reasons', 'Food as reward', 'Teaching nutrition', 'Modeling' , 'Responsibility'. Higher scores mean higher behaviors.

    Measured: at the ages of 12, 24, 36 months

  7. Parental feeding practices (behavioral observation)

    Filmed meal at the laboratory at the age of 36 months to observe parental strategies for coping with food refusal (parents will choose from a selection a vegetable that is not appreciated by the child. The strategies the parent will use to get the food tasted will be recorded.)

    + Filmed meal at participants' home at the age of 32 months in order to assess the quality of interactions in a more natural context.

    The overall behaviors of the infant during the meal (e.g.: "turns his head", "signals with his hand that he is no longer hungry", etc.) as well as the behaviors of the parent who feeds (e.g.: "talks to encourage her infant", "takes a break from feeding", "flys the plane with the spoon", etc.) will be described on the basis of a video analysis thanks to the establishment of ethograms.

    Measured: at the ages of 32 and 36 months

  8. Introduction of complementary foods

    Parent-reports using a questionnaire from a previous research (RCT ECAIL). This questionnaire is composed of 93 items relating to breastfeeding (age of stopping and reasons), milks (type of milks offered to the baby), age and reasons for starting complementary feeding (CF) and items representing different drinks and complementary foods. Parent answers to each food item using a 5-category scale (not yet introduced, only once, 2 or 3 times, more often, every day or almost every day) (higher scores mean higher consumption frequency) and indicates the age of introduction as soon as the consumption frequency is higher than 'only once'.

    Particular interest will be given to : 'age at the start of CF', 'reasons for starting CF', 'diversity of foods introduced between 4 and 6 months', 'diversity of major allergens introduced between 4 and 6 months', 'consumption frequency' and 'age of introduction' of various food groups.

    Measured: at the ages of 3, 6, 12, 18, 24, 36, 48 months

  9. Food frequency and food acceptance

    Parent-reports using a questionnaire from a previous research (ANR OPALINE). This questionnaire is composed of 257 food items. Parent answers to each item using a 5-category scale (almost every day, 1 to 3 times a week, 1 to 3 times per month, less than once a month, never) to assess frequency (higher scores mean higher consumption frequency) and using a 4-point scale (++, +, -, --) to assess liking (higher scores mean higher liking).

    Measured: at the age of 36 months

  10. Food texture exposure and acceptance

    Parent-reports using a summarized version of a questionnaire developed to characterize the pattern of food texture exposure in French children aged 4-36 months. This questionnaire is composed of items representing foods commonly used in France in different texture combinations (puree, pieces, raw, cooked, etc.)). Parent answers to each item using a 4-category scale (not offered, spit out, eaten with difficulty, eaten without difficulty). Higher scores mean higher behaviors.

    Measured: at the age of 12 months

  11. Child feeding skills

    Parents will report children general feeding skills (holding a spoon in the mouth alone, eating with fingers, self-feeding with a fork, etc.) on a 5-category scale (often, sometimes, rarely, never, I don't know). Higher scores mean higher feeding skills.

    Measured: at the ages of 12 and 36 months

  12. Meal context - FPSQ

    Parent-reports at the ages of 12, 24, 36 months using translated extracts from the validated Feeding Practices and Structure Questionnaire. Parent answers to 7 items using a 5-category scale (never, rarely, sometimes, often, always). Items are grouped to define 3 dimensions : 'Family meal setting', ' Structured Meal Timing', 'Structured Meal Setting '. Higher scores mean higher behaviours.

    Measured: at the ages of 12, 24, 36 months

  13. Meal context - FFBS

    Parent-reports at the ages of 12, 24, 36 months using translated extracts from the validated Family Food Behavior Survey. Parent answers to 12 items using a 5-category scale (never true, rarely true, sometimes true, often true, always true). Items are grouped to define 2 dimensions : 'Maternal control' and 'Organization of eating environment'. Higher scores mean higher behaviours.

    Measured: at the ages of 12, 24, 36 months

  14. Maternal distractions during feeding - Use of technological distractors

    Parent-reports at the ages of 12, 24, 36 months using an adapted version of the Maternal Distraction Questionnaire which is a validated questionnaire. Higher scores mean higher behaviour.

    Measured: at the ages of 12, 24, 36 months

  15. Maternal distractions during feeding - Perceived Distraction

    Parent-reports at the ages of 12, 24, 36 months using an adapted version of the Maternal Distraction Questionnaire which is a validated questionnaire. Higher scores mean higher perception

    Measured: at the ages of 12, 24, 36 months

  16. Knowledge about infant nutrition

    Parent-reports using a questionnaire developped by De Rosso et al. (in press). This questionnaire is composed of 30 items representing various infant feeding recommendations. Parent first answers to each item on a dichotomous true/false scale and then indicates how sure he/she is of his/her answer on a 4-category scale (I am not at all sure, I am rather unsure, I am rather sure, I am completely sure). Two dimensions are assessed : Knowledge accuracy and Knowledge certainty.Higher scores mean higher accuracy/certainty.

    Measured: at the age of 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285761
Sponsor's protocol ID
2020-A01941-38
Acronym
NUTRIENT
Status last verified
Mar 2024
First submitted
3 Mar 2022
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication will be shared

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 17535817
  • 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.

    PubMed 31999399
  • 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.

    PubMed 33598476
  • 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.

    PubMed 31370830
  • 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.

    PubMed 32025583
  • 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.

    PubMed 39334106

Questions about this trial

What is this clinical trial studying?

A study testing Provision of extended information on the conduct of complementary feeding and Provision of current official information on complementary feeding in people with Healthy Volunteers, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Camille Schwartz, PhD (00 333 80 69 37 43, camille.schwartz@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index z-score at the age of 36 months (time frame: End of intervention (at the age of 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05285761, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in