Food HabitsNCT03400566
Effects of Experiential Learning on Vegetable Intake in Preschool Children
A study testing Narrative and Experiential in people with Food Habits and Food Preferences, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years). Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Habits, Food Preferences, Health Behavior
- What is being tested?
- Narrative and Experiential
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2017to 5 Jan 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 to 5 years old
- Attends nursery on selected test day
Who cannot join
- Relevant food allergy (celeriac / celery)
- Medical condition which would prevent them from eating the test vegetable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Psychology, University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Effects of Congruent and In-congruent Experiential Learning on Intake of a Novel Vegetable in Preschool Children
The aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).
Read the detailed description
The aim of this study is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years). In particular, the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters.
There are two manipulations in this study - the provision of a story which features either a target vegetable (celeriac) or a control vegetable (carrot) and the presence of experiential learning (smelling, touching, looking at the vegetable) with either the target vegetable or the control vegetable.
Baseline consumption and familiarity of the target veg will be assessed for all children, before the intervention. The intervention consists of two familiarization trials, and 2-weeks of access to a story book featuring vegetables. Following the final familiarization trial, consumption and familiarity will be assessed again. Each familiarization trial consists of a story in class, and depending on condition, an experiential learning episode in class. During the 2 week interval between familiarization sessions nurseries will be requested to ready the story book 5 times in the preschool room (at times convenient to them).
Participants will be cluster randomized into 4 groups (2X2 between subjects design): 1) target vegetable narrative, 2) target vegetable narrative + experiential, 3) control vegetable narrative 4) control vegetable narrative + experiential
Child's food fussiness data will be collected by parents using the Food Fussiness sub scale of the Child Eating Behaviour Questionnaire. Their usual consumption of the target vegetable will also be measured using parent report.
Nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.
It is predicted that children's intake of the novel vegetable will vary by intervention. The primary hypothesis to be tested is that providing experience of a target novel vegetable within the context of an interactive story time will encourage preschoolers to taste, try and eat the target vegetable.
- Conditions
- Food Habits, Food Preferences, Health Behavior, Diet Habit, Child Behavior
- Being tested
- Narrative, Experiential
- Medical subject headings
- Feeding Behavior, Food Preferences, Health Behavior, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NarrativeBehavioural
Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
ExperientialBehavioural
Children will receive hands on experience with the vegetable. They will get to listen, see, feel, touch and smell the actual vegetable during the two familiarization phases.
| Study group | Role | What they receive |
|---|---|---|
| Narrative (target) | Experimental | Children will receive the story featuring the target vegetable and NO sensory experience. Receives: Behavioral: Narrative |
| Narrative+ experiential (target) | Experimental | Children will receive the story featuring the target vegetable and experiential learning with the target vegetable. Receives: Behavioral: Narrative; Behavioral: Experiential |
| Narrative (control) | Active comparator | Children will receive the story featuring the control vegetable and NO sensory experience. Receives: Behavioral: Narrative |
| Narrative+ experiential (control) | Active comparator | Children will receive the story featuring the control vegetable and experiential learning with the control vegetable. Receives: Behavioral: Narrative; Behavioral: Experiential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intake of the target vegetable
Intake of the novel vegetable will be measured at baseline (day 1) and post intervention (day 14). Intake of the novel vegetable will be measured individually and objectively using weight in grams. Change in intake will be calculated by subtraction of baseline intake from post intervention intake.
Measured: Change in intake of the target vegetable from Baseline to day 14
Secondary outcomes (1)
Knowledge of the target vegetable
Children's knowledge of the target vegetable will be assessed at baseline (day 1) and post intervention (day 14). Children will be asked to name the photo card featuring the target vegetable.
Measured: Knowledge of the target vegetable at day 14 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start2 Oct 2017
- Primary completion30 Nov 2017
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom, Purely Nutrition Ltd
- Responsible party
- Principal investigator, Chandani Nekitsing, University of Leeds
- Investigators
- Chandani Nekitsing, MSc, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400566
- Sponsor's protocol ID
- ULeeds
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nekitsing C, Blundell-Birtill P, Cockroft JE, Fildes A, Hetherington MM. Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2014-2027. doi: 10.1016/j.jand.2019.05.017. Epub 2019 Aug 1.
PubMed 31378648Nekitsing C, Blundell-Birtill P, Cockroft JE, Hetherington MM. Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2004-2013. doi: 10.1016/j.jand.2019.05.012. Epub 2019 Aug 1.
PubMed 31378647
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Congruent and In-congruent Experiential Learning on Intake of a Novel Vegetable in Preschool Children
- ClinicalTrials.gov ID
- NCT03400566
- Acronym / sponsor ID
- ULeeds
- Conditions
- Food Habits, Food Preferences, Health Behavior, Diet Habit, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom, Purely Nutrition Ltd
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 17 Jan 2018 (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 aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).
Detailed description
The aim of this study is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years). In particular, the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters.
There are two manipulations in this study - the provision of a story which features either a target vegetable (celeriac) or a control vegetable (carrot) and the presence of experiential learning (smelling, touching, looking at the vegetable) with either the target vegetable or the control vegetable.
Baseline consumption and familiarity of the target veg will be assessed for all children, before the intervention. The intervention consists of two familiarization trials, and 2-weeks of access to a story book featuring vegetables. Following the final familiarization trial, consumption and familiarity will be assessed again. Each familiarization trial consists of a story in class, and depending on condition, an experiential learning episode in class. During the 2 week interval between familiarization sessions nurseries will be requested to ready the story book 5 times in the preschool room (at times convenient to them).
Participants will be cluster randomized into 4 groups (2X2 between subjects design): 1) target vegetable narrative, 2) target vegetable narrative + experiential, 3) control vegetable narrative 4) control vegetable narrative + experiential
Child's food fussiness data will be collected by parents using the Food Fussiness sub scale of the Child Eating Behaviour Questionnaire. Their usual consumption of the target vegetable will also be measured using parent report.
Nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.
It is predicted that children's intake of the novel vegetable will vary by intervention. The primary hypothesis to be tested is that providing experience of a target novel vegetable within the context of an interactive story time will encourage preschoolers to taste, try and eat the target vegetable.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Narrative (target) | Experimental | Behavioral: NarrativeChildren will receive the story featuring the target vegetable and NO sensory experience. |
| Narrative+ experiential (target) | Experimental | Behavioral: Narrative, Behavioral: ExperientialChildren will receive the story featuring the target vegetable and experiential learning with the target vegetable. |
| Narrative (control) | Active comparator | Behavioral: NarrativeChildren will receive the story featuring the control vegetable and NO sensory experience. |
| Narrative+ experiential (control) | Active comparator | Behavioral: Narrative, Behavioral: ExperientialChildren will receive the story featuring the control vegetable and experiential learning with the control vegetable. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2 to 5 years old
- Attends nursery on selected test day
Key exclusion criteria (2 listed)
- Relevant food allergy (celeriac / celery)
- Medical condition which would prevent them from eating the test vegetable
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 |
|---|---|---|
| NarrativeChildren will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase). | Behavioural | Narrative (control), Narrative (target), Narrative+ experiential (control), Narrative+ experiential (target) |
| ExperientialChildren will receive hands on experience with the vegetable. They will get to listen, see, feel, touch and smell the actual vegetable during the two familiarization phases. | Behavioural | Narrative+ experiential (control), Narrative+ experiential (target) |
Primary outcome
Change in intake of the target vegetable
Time frame: Change in intake of the target vegetable from Baseline to day 14
Intake of the novel vegetable will be measured at baseline (day 1) and post intervention (day 14). Intake of the novel vegetable will be measured individually and objectively using weight in grams. Change in intake will be calculated by subtraction of baseline intake from post intervention intake.
1 secondary outcome
Knowledge of the target vegetable
Time frame: Knowledge of the target vegetable at day 14 (post intervention)
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 17 Jan 2018.
- Derived from this study: PubMed 31378648Nekitsing C, Blundell-Birtill P, Cockroft JE, Fildes A, Hetherington MM. Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2014-2027. doi: 10.1016/j.jand.2019.05.017. Epub 2019 Aug 1.
- Derived from this study: PubMed 31378647Nekitsing C, Blundell-Birtill P, Cockroft JE, Hetherington MM. Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2004-2013. doi: 10.1016/j.jand.2019.05.012. Epub 2019 Aug 1.
- Individual participant dataSharing planned: Undecided
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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.
Chandani Nekitsing, MSc principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative and Experiential in people with Food Habits and Food Preferences, run by University of Leeds at 1 site in United Kingdom.
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 2 inclusion and 2 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 17 Jan 2018. 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 United Kingdom. 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?
Change in intake of the target vegetable (time frame: Change in intake of the target vegetable from Baseline to day 14). 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 NCT03400566, which also lists 2 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 17 Jan 2018.