Food HabitsNCT03003923
Promoting Vegetable Intake in Preschool Aged Children
A study testing Taste exposure and Nutritional education 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 randomised control trial is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 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, Behavior
- What is being tested?
- Taste exposure and Nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Aug 2017
- 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 (mooli / radish)
- 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: A Randomised Control Trial of an Educational and Taste-exposure Intervention to Promote Vegetable Intake in Preschool Aged Children
The aim of this cluster randomised control trial is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).
Read the detailed description
The aim of this study is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 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 or going through the food neophobia phase. The effectiveness of these interventions will also be observed overtime at 3 and 6 months post intervention.
Nurseries will be randomised into one of four conditions over the 12 week intervention period; these include educational intervention only, taste exposures only, taste exposures and educational intervention or no intervention (control group). All children will be offered an unfamiliar vegetable prior to the intervention and after the intervention to evaluate changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the educational intervention nursery staff will be advised to deliver two components of an existing PhunkyFoods educational programme over the same period.
Parents will be asked some general demographic questions, child food behaviour questions and questions about their feeding practices. Finally nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.
It is predicted that children's intake of the unfamiliar vegetable will vary by intervention. The primary hypothesis to be tested is that children who receive the repeated taste exposures are more likely to increase their intake of the unfamiliar vegetable compared to those in educational only or control conditions. The second hypothesis is that repeated taste exposures will increase intake of an unfamiliar vegetable in fussy eaters more than education.
- Conditions
- Food Habits, Food Preferences, Behavior, Health Behavior
- Being tested
- Taste exposure, Nutritional education
- Keywords
- Vegetable intake, Taste exposures, Educational intervention, Preschool children, Healthy eating intervention
- Medical subject headings
- Feeding Behavior, Food Preferences, Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste exposureBehavioural
Exposure to the same vegetable
Nutritional educationBehavioural
Eat Well and Strive for Five nutritional education
| Study group | Role | What they receive |
|---|---|---|
| Taste Exposure | Experimental | Children will be repeatedly offered the single vegetable which is unfamiliar to them over the 12 week period. Children will be in their natural setting at nursery and will be offered 40g of the vegetable by their usual nursery staff. The vegetable will be weighed before and after using a digital scale by the researcher. Receives: Behavioral: Taste exposure |
| Nutritional Education | Experimental | Nursery staff will be trained by the PhunkyFoods team to deliver the nutritional education programme. Children will be taught Eat Well (learning about different food groups) and Strive for Five (learning about eating fruits and vegetables) components of the PhunkyFoods education programme by their usual nursery staff. Nurseries will be advised to deliver as much as possible of the two components over the 12 week period. Receives: Behavioral: Nutritional education |
| Taste Exposure and Nutritional Education | Experimental | Children will be repeatedly offered a single unfamiliar vegetable over the 12 week period as well as receive the PhunkyFoods educational programme (Eat Well and Strive for Five components). Children will be in their natural setting at nursery and will be offered the vegetable and nutritional education by their usual nursery staff. Receives: Behavioral: Taste exposure; Behavioral: Nutritional education |
| Control | No intervention | Children will be offered single unfamiliar vegetable at the beginning, end and at the follow-up. There will be no repeated taste exposure or education during the study phase or follow-up; they will be offered the nutritional education after the study has completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of an unfamiliar vegetable
Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-ups 3 (week 24) and 6 months (week 36) later. Intake of unfamiliar vegetable will be measured individually and objectively using weight in grams.
Measured: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)
Secondary outcomes (1)
Intake of usual vegetables
Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-up 3 months later (week 24). Intake of usual vegetable will be measured using a Food Frequency Questionnaire.
Measured: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Purely Nutrition Ltd, Economic and Social Research Council, United Kingdom
- 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
- NCT03003923
- Sponsor's protocol ID
- Chandani Nekitsing
- Status last verified
- Jan 2018
- First submitted
- 15 Dec 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of an Educational and Taste-exposure Intervention to Promote Vegetable Intake in Preschool Aged Children
- ClinicalTrials.gov ID
- NCT03003923
- Acronym / sponsor ID
- Chandani Nekitsing
- Conditions
- Food Habits, Food Preferences, Behavior, Health Behavior
- Keywords
- Vegetable intake, Taste exposures, Educational intervention, Preschool children, Healthy eating intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Purely Nutrition Ltd, Economic and Social Research Council, United Kingdom
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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 randomised control trial is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).
Detailed description
The aim of this study is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 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 or going through the food neophobia phase. The effectiveness of these interventions will also be observed overtime at 3 and 6 months post intervention.
Nurseries will be randomised into one of four conditions over the 12 week intervention period; these include educational intervention only, taste exposures only, taste exposures and educational intervention or no intervention (control group). All children will be offered an unfamiliar vegetable prior to the intervention and after the intervention to evaluate changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the educational intervention nursery staff will be advised to deliver two components of an existing PhunkyFoods educational programme over the same period.
Parents will be asked some general demographic questions, child food behaviour questions and questions about their feeding practices. Finally nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.
It is predicted that children's intake of the unfamiliar vegetable will vary by intervention. The primary hypothesis to be tested is that children who receive the repeated taste exposures are more likely to increase their intake of the unfamiliar vegetable compared to those in educational only or control conditions. The second hypothesis is that repeated taste exposures will increase intake of an unfamiliar vegetable in fussy eaters more than education.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Taste Exposure | Experimental | Behavioral: Taste exposureChildren will be repeatedly offered the single vegetable which is unfamiliar to them over the 12 week period. Children will be in their natural setting at nursery and will be offered 40g of the vegetable by their usual nursery staff. The vegetable will be weighed before and after using a digital scale by the researcher. |
| Nutritional Education | Experimental | Behavioral: Nutritional educationNursery staff will be trained by the PhunkyFoods team to deliver the nutritional education programme. Children will be taught Eat Well (learning about different food groups) and Strive for Five (learning about eating fruits and vegetables) components of the PhunkyFoods education programme by their usual nursery staff. Nurseries will be advised to deliver as much as possible of the two components over the 12 week period. |
| Taste Exposure and Nutritional Education | Experimental | Behavioral: Taste exposure, Behavioral: Nutritional educationChildren will be repeatedly offered a single unfamiliar vegetable over the 12 week period as well as receive the PhunkyFoods educational programme (Eat Well and Strive for Five components). Children will be in their natural setting at nursery and will be offered the vegetable and nutritional education by their usual nursery staff. |
| Control | No intervention | –Children will be offered single unfamiliar vegetable at the beginning, end and at the follow-up. There will be no repeated taste exposure or education during the study phase or follow-up; they will be offered the nutritional education after the study has completed. |
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 (mooli / radish)
- 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 |
|---|---|---|
| Taste exposureExposure to the same vegetable | Behavioural | Taste Exposure, Taste Exposure and Nutritional Education |
| Nutritional educationEat Well and Strive for Five nutritional education | Behavioural | Nutritional Education, Taste Exposure and Nutritional Education |
Primary outcome
Intake of an unfamiliar vegetable
Time frame: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)
Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-ups 3 (week 24) and 6 months (week 36) later. Intake of unfamiliar vegetable will be measured individually and objectively using weight in grams.
1 secondary outcome
Intake of usual vegetables
Time frame: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)
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 9 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Food Habits
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Not yet recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
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 Taste exposure and Nutritional education 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 9 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?
Intake of an unfamiliar vegetable (time frame: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.