ClinicalTrials.gg
CompletedNCT04570059PATATEUpdated Sep 30, 2020

Textured Food Introduction Information and Parental Feeding Practices

An interventional study of Counselling on textured food introduction between 8 and 15 months in Feeding Practices and Food Acceptance, sponsored by Centre des Sciences du Goût et de l'Alimentation. Completed at 1 site in France. Open to participants aged 1 Month to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-30.

Sponsored by Centre des Sciences du Goût et de l'Alimentation · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Nov 2016, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
1 Month to 7 Months
Sex
All
01

Study summary

The purpose of this study is to conduct an intervention with 60 parents of 8 months old children to test the effect of recommendations, compared to usual care, promoting the introduction of textured foods between 8 and 15 months on parental practices of use of textured foods and the effect of such practices on children acceptance for a variety of textured foods.

Read the detailed description

The intervention tests the effect of providing parents with recommendations on textured food introduction between 8 and 15 months on their practices of offering of textured foods and their child's acceptance of textured foods. The intervention consists of advice and tips on the why and how introducing textured food during complementary feeding, which were not address in French national guidelines (Programme National Nutrition Santé (PNNS)) at the start of the study. Advise were developped from current literature knowledge and recommendations in other countries. They are accompanied with monthly counselling via phone calls by dietician and two baskets containing food preparation utensils and commercial textured foods. The intervention group (n=30) benefits from this intervention. The control group (n=30) receive general information on healthy eating provided by the food guides of the PNNS, phone calls collecting general information and 2 baskets containing baby gifts.

Acceptance is evaluated experimentally pre and post intervention in a laboratory setting evaluating children swallowing foods of different textures.

02

Conditions studied

  • Feeding Practices
  • Food Acceptance

Keywords

  • children
  • parental feeding practices
  • food texture
  • food oral processing
  • complementary feeding
  • recommendation
03

In context

Lead sponsor

Centre des Sciences du Goût et de l'Alimentation is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 7 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • parents ages ≥ 18 years old
  • children born full term (≥37 weeks) and with weight ≥2500 g
  • children introduced to complementary feeding after 4 months and before 6 months

Exclusion criteria

Exclusion Criteria:

  • children with episode of tube feedings, chronic disease, allergy and gastroesophageal reflux requiring medication
  • children introduced to complementary feeding with baby-led weaning method
  • children already involved in another study on eating behaviour
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Intervention program

    Intervention group

    Behavioral: Counselling on textured food introduction between 8 and 15 months

  • Active comparator
    Usual Care

    Control group

    Behavioral: Counselling on textured food introduction between 8 and 15 months

Interventions

  • BehavioralCounselling on textured food introduction between 8 and 15 months

    Intervention program : Advice and tips on the why and how introducing textured food during complementary feeding are grouped in a booklet and provided to participants. Monthly counselling via phone call by a dietician (at 9, 10, 11,12, 13, 14 months) and two baskets containing food preparation utensils and commercial textured foods provided at 8 and 12 months. Usual care : reflects the standard information provided within French national guidelines (PNNS). Two phone calls at 9 and 13 months. If questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS. Two gift boxes containing presents for the child of same financial value as those provided to intervention group, provided at 8 and 12 months.

    Also known as: Food provision

06

What researchers measure

Primary outcomes

  1. Food texture exposure score

    Food texture introduction assessed using a questionnaire developed to characterize the pattern of food texture exposure in French children aged 4-36 months (Demonteil et al., 2018). This questionnaire is composed of 188 items representing 61 foods commonly used in France in different texture combinations (puree, pieces, raw, cooked, etc.). Each food-texture combination present in the questionnaire is classified into one of three texture levels: 'purees' (soft and rough; T1 texture level), 'small/soft pieces' (T2 texture level) and 'hard/big pieces and double texture' (T3 texture level) . The number of introduced items is evaluated for each texture level (T1, T2 and T3), and a global child exposure score (TexExp) is calculated from the sum of all introduced items.

    Time frame: End of intervention (15 months)

  2. Textured food acceptance: scale

    Food texture acceptance is assessed during lab experiments. At each age, children participate in two experimental sessions in which they are offered several foods varying in texture. For each age, for a given child, the two sessions are planned during the same week. During one session, four different foods are offered to the child. Three trials of each food is run, trial offering is stopped after three consecutive refusals is emitted by the child. Experimenter evaluate whether the child swallow the trial. Acceptance is determined for each food as % of trial swallowed. Global acceptance outcome is calculated as the sum of frequency observed for each food. Parents evaluate the infant's liking of the food on a linear scale for each food trial. At the end of intervention, acceptance for 2 commercial baby food products is assessed by parents in home-setting. The parent records the weight of food eaten (g) and children 's liking of this food on a 9 point scale.

    Time frame: Pre and post intervention (8 and 15 months)

Secondary outcomes

  1. Other maternal feeding practices

    At the end of intervention, parents report if they search for information on texture introduction during the study. The type of foods offered (home-made or commercial foods), sharing meal with family and their motivation when buying food is assessed using dedicated questionnaires. A post-intervention interviews, organized after the end of the study allow to debrief with participants on their study participation.

    Time frame: end of intervention (15 months)

  2. Child feeding skills

    During the experimental session aiming at evaluating acceptance, the experimenter evaluate a set of behaviours : 'looks at the food', 'manipulate the food with fingers', 'puts the foods in the mouth with fingers/spoon', 'sucking', 'gagging', 'chewing', 'coughing/risk of chocking', 'has difficulties wih the food'. Parents will report children general feeding skills (holding a spoon in the mouth alone, eating with fingers, self-feeding with a fork, gagging) on a 4-point scale.

    Time frame: Pre and post intervention (8 and 15 months)

  3. Number of teeth

    Parents report the number of teeth visible in their child mouth

    Time frame: Pre and post intervention (8 and 15 months)

  4. Children chewing efficiency

    Determined during experimental session from children's ability to comminute a model gel. The gel is inserted in a mesh feeder and offered to the child for a 60s oral processing duration. Gel particles are collected from the feeder and photographed. The number of formed particles is used as marker of chewing efficiency.

    Time frame: Pre and post intervention (8 and 15 months)

  5. Salivary flow rate

    Measured during experimental session using a cotton swab method (Salivette®, Sarsedt) for a 45-sec duration. Saliva collection was realized by the parent maintaining the swab for 45 seconds in child's mouth. The weight of the swab (g) is determined before and after collection and the exact exposure time (sec) is measured by the experimenter. Mesured weight and time are combined to determine flow rate (in g.min-1).

    Time frame: Pre and post intervention (8 and 15 months)

  6. Children eating behaviour

    Parent-reports using a 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 over-eating', and 'external food cue responsiveness'.Higher scores mean higher behaviours.

    Time frame: 12 months

07

Study locations

1 site
  • Centre des Sciences du Goût et de l'Alimentation
    Dijon, 21000, France
08

References and documents

Publications

  • Demonteil L, Ksiazek E, Marduel A, Dusoulier M, Weenen H, Tournier C, Nicklaus S. Patterns and predictors of food texture introduction in French children aged 4-36 months. Br J Nutr. 2018 Nov;120(9):1065-1077. doi: 10.1017/S0007114518002386. Epub 2018 Sep 11. PubMed 30203737 ↗
  • Tournier C, Demonteil L, Canon F, Marduel A, Feron G, Nicklaus S. A new masticatory performance assessment method for infants: A feasibility study. J Texture Stud. 2019 Jun;50(3):237-247. doi: 10.1111/jtxs.12388. Epub 2019 Feb 3. PubMed 30667063 ↗
  • Demonteil, L., et al. (2019).Longitudinal study on acceptance of food textures between 6 and 18 months. Food Quality and Preference 71: 54-65.
  • Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792. PubMed 11693591 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2016 to primary completion in Jul 2017, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2020
First posted
Sep 30, 2020
StartActual
Nov 1, 2016
Primary completionActual
Jul 13, 2017
CompletionActual
Apr 16, 2018
Last update
Sep 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04570059
Lead sponsor
Centre des Sciences du Goût et de l'Alimentation
Collaborators
UMR SayFood, Massy, France, Funding from Carnot Qualiment (Project PATATE)
Responsible party
Sponsor
First posted
Sep 30, 2020
Start date
Nov 1, 2016
Primary completion
Jul 13, 2017
Completion
Apr 16, 2018
Last update
Sep 30, 2020

Study contacts

Carole Tournier, PhD
principal investigator · INRAE UMR CSGA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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