Textured Food Introduction Information and Parental Feeding Practices

NCT04570059 | Completed DMC

• 1 other identifier: ID RCB 2016-A00839-42
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feeding Practices; Food Acceptance

Keywords

children; parental feeding practices; food texture; food oral processing; complementary feeding; recommendation

Outcome Measures

Primary Outcomes (2)

• 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.

  End of intervention (15 months)

• 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.

  Pre and post intervention (8 and 15 months)

Secondary Outcomes (6)

• Other maternal feeding practices

  end of intervention (15 months)

• Child feeding skills

  Pre and post intervention (8 and 15 months)

• Number of teeth

  Pre and post intervention (8 and 15 months)

• Children chewing efficiency

  Pre and post intervention (8 and 15 months)

• Salivary flow rate

  Pre and post intervention (8 and 15 months)

Study Arms (2)

Intervention program

EXPERIMENTAL

Intervention group

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

Usual Care

ACTIVE COMPARATOR

Control group

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

Interventions

Counselling on textured food introduction between 8 and 15 months BEHAVIORAL

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

Intervention program; Usual Care

Eligibility Criteria

• Age: 1 Month - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• UMR SayFood, Massy, France: collaborator
• Funding from Carnot Qualiment (Project PATATE): collaborator

Study Sites (1)

Centre des Sciences du Goût et de l'Alimentation

Dijon, 21000, France

Location

Related Publications (4)

• 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.

  PMID: 30203737 BACKGROUND

• 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.

  PMID: 30667063 BACKGROUND

• Demonteil, L., et al. (2019).Longitudinal study on acceptance of food textures between 6 and 18 months. Food Quality and Preference 71: 54-65.

  BACKGROUND

• 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.

  PMID: 11693591 BACKGROUND

Study Officials

• Carole Tournier, PhD

  INRAE UMR CSGA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Parents are informed that the aim of the study was about the effect of complementary feeding recommendations on their child's eating behaviour but they are unaware of the focus on texture. They are also blinded to the group (intervention vs. control) to which they were allocated. This information is revealed to them after the end of the study. The principal investigator analyse the data without information on children allocation and groups effect are initially assessed without identification of participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention run between 8 and 15 months of the children, randomisation of children within a control (n=30) or intervention group (n=30).

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 30, 2020
• Study Start: November 1, 2016
• Primary Completion: July 13, 2017
• Study Completion: April 16, 2018
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)