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Textured Food Introduction Information and Parental Feeding Practices

NCT ID: NCT04570059

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2018-04-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Feeding Practices Food Acceptance

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Intervention program

Intervention group

Group Type EXPERIMENTAL

Counselling on textured food introduction between 8 and 15 months

Intervention Type 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.

Usual Care

Control group

Group Type ACTIVE_COMPARATOR

Counselling on textured food introduction between 8 and 15 months

Intervention Type 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.

Interventions

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Counselling 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Food provision

Eligibility Criteria

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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

* 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UMR SayFood, Massy, France

UNKNOWN

Sponsor Role collaborator

Funding from Carnot Qualiment (Project PATATE)

UNKNOWN

Sponsor Role collaborator

Centre des Sciences du Goût et de l'Alimentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carole Tournier, PhD

Role: PRINCIPAL_INVESTIGATOR

INRAE UMR CSGA

Locations

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Centre des Sciences du Goût et de l'Alimentation

Dijon, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 30203737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30667063 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11693591 (View on PubMed)

Study Documents

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Document Type: intervention material

View Document

Other Identifiers

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ID RCB 2016-A00839-42

Identifier Type: -

Identifier Source: org_study_id