Feeding PracticesPATATENCT04570059
Textured Food Introduction Information and Parental Feeding Practices
A study testing Counselling on textured food introduction between 8 and 15 months in people with Feeding Practices and Food Acceptance, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding Practices, Food Acceptance
- What is being tested?
- Counselling on textured food introduction between 8 and 15 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2016to 16 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Information Promoting Textured Food Introduction on Parental Practices and Children Acceptance of Textured Foods
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.
- Conditions
- Feeding Practices, Food Acceptance
- Being tested
- Counselling on textured food introduction between 8 and 15 months
- Keywords
- children, parental feeding practices, food texture, food oral processing, complementary feeding, recommendation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling on textured food introduction between 8 and 15 monthsBehavioural
Also called Food provision
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention program | Experimental | Intervention group Receives: Behavioral: Counselling on textured food introduction between 8 and 15 months |
| Usual Care | Active comparator | Control group Receives: Behavioral: Counselling on textured food introduction between 8 and 15 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre and post intervention (8 and 15 months)
Secondary outcomes (6)
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.
Measured: end of intervention (15 months)
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.
Measured: Pre and post intervention (8 and 15 months)
Number of teeth
Parents report the number of teeth visible in their child mouth
Measured: Pre and post intervention (8 and 15 months)
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.
Measured: Pre and post intervention (8 and 15 months)
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).
Measured: Pre and post intervention (8 and 15 months)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Nov 2016
- Primary completion13 Jul 2017
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Feeding PracticesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 8 and 15 months of the children, randomisation of children within a control (n=30) or intervention group (n=30).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- UMR SayFood, Massy, France, Funding from Carnot Qualiment (Project PATATE)
- Responsible party
- Sponsor
- Investigators
- Carole Tournier, PhD, Principal investigator, INRAE UMR CSGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570059
- Sponsor's protocol ID
- ID RCB 2016-A00839-42
- Acronym
- PATATE
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30203737Tournier 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 30667063Demonteil, 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Information Promoting Textured Food Introduction on Parental Practices and Children Acceptance of Textured Foods
- ClinicalTrials.gov ID
- NCT04570059
- Acronym / sponsor ID
- PATATE / ID RCB 2016-A00839-42
- Conditions
- Feeding Practices, Food Acceptance
- Keywords
- children, parental feeding practices, food texture, food oral processing, complementary feeding, recommendation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- UMR SayFood, Massy, France, Funding from Carnot Qualiment (Project PATATE)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intervention run between 8 and 15 months of the children, randomisation of children within a control (n=30) or intervention group (n=30).
| Arm | Type | Receives |
|---|---|---|
| Intervention program | Experimental | Behavioral: Counselling on textured food introduction between 8 and 15 monthsIntervention group |
| Usual Care | Active comparator | Behavioral: Counselling on textured food introduction between 8 and 15 monthsControl group |
Who may qualify
- Ages
- 1 month to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling on textured food introduction between 8 and 15 monthsAlso: Food provisionIntervention 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. | Behavioural | Intervention program, Usual Care |
Primary outcome
Food texture exposure score
Time frame: End of intervention (15 months)
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.
Textured food acceptance: scale
Time frame: Pre and post intervention (8 and 15 months)
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.
6 secondary outcomes
Other maternal feeding practices
Time frame: end of intervention (15 months)
Child feeding skills
Time frame: Pre and post intervention (8 and 15 months)
Number of teeth
Time frame: Pre and post intervention (8 and 15 months)
Children chewing efficiency
Time frame: Pre and post intervention (8 and 15 months)
Salivary flow rate
Time frame: Pre and post intervention (8 and 15 months)
Children eating behaviour
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 30203737Demonteil 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.
- Background: PubMed 30667063Tournier 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.
- BackgroundDemonteil, L., et al. (2019).Longitudinal study on acceptance of food textures between 6 and 18 months. Food Quality and Preference 71: 54-65.
- Background: PubMed 11693591Wardle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Tournier, PhD principal investigator
INRAE UMR CSGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling on textured food introduction between 8 and 15 months in people with Feeding Practices and Food Acceptance, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food texture exposure score (time frame: End of intervention (15 months)). The study lists 2 primary outcomes in all. 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 NCT04570059, which also lists 4 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 30 Sep 2020.