Nutrition, HealthyVOHENCT06212375
Vegetable Offering in the Home Environment - Impact of Free Accessibility and Choice on Snack Vegetable Intake
A study testing Vegetable variety and Vegetable offering strategy in people with Nutrition, Healthy, run by Wageningen University at 1 site in Netherlands.
Trial summary
This study examines the impact of offering strategies on the fruit and vegetable intake of children aged 4-6. Two key factors being explored are whether caregivers initiate the offering or if it's freely provided and whether children have a choice in selecting fruits and vegetables. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Vegetable variety and Vegetable offering strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Oct 2023to 1 Feb 2024
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children should be between 4-7 years old;
- Children should spend 2 out of 5 afternoons at home on school days, while there is also a caregiver present to offer the vegetables;
- Both caregivers as well as the child are willing to comply to the study procedure;
Who cannot join
- Children who have any allergies or intolerances to the fruits and vegetables used in the study;
- Not willing to eat the test foods because of eating habits or beliefs as indicated by parent or caregiver;
Trial locations and contacts
1 site in 1 country.
Marlou L Lasschuijt, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research
Wageningen, Gelderland, 6708 WE
Femke J de Gooijer, MSc, +31612156023, femke.degooijer@wur.nl
Guido Camps, PhD, guido.camps@wur.nl
About this study
This study examines the impact of offering strategies on the fruit and vegetable intake of children aged 4-6. Two key factors being explored are whether caregivers initiate the offering or if it's freely provided and whether children have a choice in selecting fruits and vegetables. The objective is to determine how these strategies affect the children's fruit and vegetable intake.
The research follows a 2x2 factorial cross-over design, with participants exposed to four different conditions. Interventions involve home visits, informed consent, questionnaires, and children tasting vegetables to assess their preferences. A SnackBox is placed in the home, and parents ensure it's filled based on the condition - children either choose a snack vegetable or have it initiated by parents. Daily questionnaires about vegetable consumption are completed, and the study concludes with material collection.
The study includes 44 children aged 4-6 and carries minimal risks with no immediate benefits. Caregivers spend around four hours participating in the study.
Read the detailed description
Rationale: The dietary habits formed during early childhood play a pivotal role in shaping long-term health outcomes. Adequate consumption of fruits and vegetables during this critical developmental period is associated with reduced risk of chronic diseases and the promotion of overall well-being. However, achieving optimal fruit and vegetable intake in young children can be challenging, and understanding the influence of offering strategies on their dietary choices is of paramount importance. The present study aims to investigate the effect of offering strategy on the fruit and vegetable intake of children aged 4-6 years old. Specifically, we will explore two key dimensions of offering strategy: (1) whether the offering is freely provided or initiated by caregivers and (2) whether children are given a choice or not in their selection of fruits and vegetables. These factors have the potential to significantly impact children's dietary behaviors.
Objective: To determine the effect of offering strategy (freely offered vs initiated and choice vs no-choice) on fruit and vegetable intake (gram) of children aged 4-6 years old.
Study design: The study will follow a 2 ((freely offered vs initiated) x 2 (choice vs no-choice) factorial cross-over design. Participants are exposed, in duplicate, to each of the four condition combinations.
Interventions: The research team visits the participants at home for an intake session, during which parents provide informed consent, complete questionnaires, and children taste the vegetables to assess their liking. During the measurement afternoons, a SnackBox is placed in the home environment, and parents ensure it is filled. Depending on the condition, parents either allow children to freely take a snack vegetable or initiate when they can eat them. Three vegetables (carrots, bell peppers, cucumbers) are offered in the choice condition, while only one vegetable is available in the no-choice condition. Parents are notified to complete a daily questionnaire about vegetable consumption during dinner at the end of each day. The research team returns to collect all study materials, concluding the study.
Study population: 44 children between 4 to 6 years old. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study is non-therapeutic to the subjects. No immediate benefits for the subjects are expected from participation in this study, and the risk associated with participation can be considered negligible. In terms of time, the subject's burden is as follows: 1 hour for the intake session and corresponding questionnaires prior to the intervention sessions for the caregiver and 15 minutes for the child; 8 times 20 minutes for completing the daily questionnaires and serving vegetables and lastly for the parent and child, 20 minutes for the wrap-up session after the intervention period. This results in a total of 4 hours for the caregiver.
- Conditions
- Nutrition, Healthy
- Being tested
- Vegetable variety, Vegetable offering strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable varietyBehavioural
Either children are offered a variety of three vegetables or a single vegetable.
Vegetable offering strategyBehavioural
Either children can decide when to eat their vegetables or parents initiate a moment.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Within subject study design: All children receive the four possible combinations of interventions. Receives: Behavioral: Vegetable variety; Behavioral: Vegetable offering strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption during the measurement afternoons
Consumption during each of the measurement afternoons is measured using the SnackBox. The SnackBox assumes consumption when decreases in weight are detected. To assess the effect of both offering strategies and there interaction, a two-way ANOVA is conducted.
Measured: 8 afternoons as chosen by the participant
Secondary outcomes (1)
true consumption
the weight of the three study-foods is measured before and after the study period is measured and additionally bought foods are registered. Pre-study weight + additionally bought foods - Post-study weight = total true consumption. The SnackBox uses an algorithm to detect decreases in weight and assumes these are due to consumption of snack vegetables. Summation of these decreases in weight results in total consumption measured by the SnackBox. Total true consumption is compared to the SnackBox measured consumption using a Bland-Altman plot and by calculating the Intra Class Correlation coefficient.
Measured: 8 afternoons as chosen by the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start17 Oct 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- OnePlanet Research Center Wageningen
- Responsible party
- Principal investigator, Marlou Lasschuijt, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212375
- Sponsor's protocol ID
- VOHEStudy
- Acronym
- VOHE
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Gooijer FJ, Camps G, Feskens EJM, Lasschuijt M. The impact of variety and free accessibility of snack vegetables on the intake of 3- to 7-year-old children: A randomized cross-over trial. Appetite. 2026 Mar 1;218:108392. doi: 10.1016/j.appet.2025.108392. Epub 2025 Nov 26.
PubMed 41314343
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegetable Offering in the Home Environment - Impact of Free Accessibility and Choice on Snack Vegetable Intake
- ClinicalTrials.gov ID
- NCT06212375
- Acronym / sponsor ID
- VOHE / VOHEStudy
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- OnePlanet Research Center Wageningen
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
This study examines the impact of offering strategies on the fruit and vegetable intake of children aged 4-6. Two key factors being explored are whether caregivers initiate the offering or if it's freely provided and whether children have a choice in selecting fruits and vegetables. The objective is to determine how these strategies affect the children's fruit and vegetable intake.
The research follows a 2x2 factorial cross-over design, with participants exposed to four different conditions. Interventions involve home visits, informed consent, questionnaires, and children tasting vegetables to assess their preferences. A SnackBox is placed in the home, and parents ensure it's filled based on the condition - children either choose a snack vegetable or have it initiated by parents. Daily questionnaires about vegetable consumption are completed, and the study concludes with material collection.
The study includes 44 children aged 4-6 and carries minimal risks with no immediate benefits. Caregivers spend around four hours participating in the study.
Detailed description
Rationale: The dietary habits formed during early childhood play a pivotal role in shaping long-term health outcomes. Adequate consumption of fruits and vegetables during this critical developmental period is associated with reduced risk of chronic diseases and the promotion of overall well-being. However, achieving optimal fruit and vegetable intake in young children can be challenging, and understanding the influence of offering strategies on their dietary choices is of paramount importance. The present study aims to investigate the effect of offering strategy on the fruit and vegetable intake of children aged 4-6 years old. Specifically, we will explore two key dimensions of offering strategy: (1) whether the offering is freely provided or initiated by caregivers and (2) whether children are given a choice or not in their selection of fruits and vegetables. These factors have the potential to significantly impact children's dietary behaviors.
Objective: To determine the effect of offering strategy (freely offered vs initiated and choice vs no-choice) on fruit and vegetable intake (gram) of children aged 4-6 years old.
Study design: The study will follow a 2 ((freely offered vs initiated) x 2 (choice vs no-choice) factorial cross-over design. Participants are exposed, in duplicate, to each of the four condition combinations.
Interventions: The research team visits the participants at home for an intake session, during which parents provide informed consent, complete questionnaires, and children taste the vegetables to assess their liking. During the measurement afternoons, a SnackBox is placed in the home environment, and parents ensure it is filled. Depending on the condition, parents either allow children to freely take a snack vegetable or initiate when they can eat them. Three vegetables (carrots, bell peppers, cucumbers) are offered in the choice condition, while only one vegetable is available in the no-choice condition. Parents are notified to complete a daily questionnaire about vegetable consumption during dinner at the end of each day. The research team returns to collect all study materials, concluding the study.
Study population: 44 children between 4 to 6 years old. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study is non-therapeutic to the subjects. No immediate benefits for the subjects are expected from participation in this study, and the risk associated with participation can be considered negligible. In terms of time, the subject's burden is as follows: 1 hour for the intake session and corresponding questionnaires prior to the intervention sessions for the caregiver and 15 minutes for the child; 8 times 20 minutes for completing the daily questionnaires and serving vegetables and lastly for the parent and child, 20 minutes for the wrap-up session after the intervention period. This results in a total of 4 hours for the caregiver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Behavioral: Vegetable variety, Behavioral: Vegetable offering strategyWithin subject study design: All children receive the four possible combinations of interventions. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children should be between 4-7 years old;
- Children should spend 2 out of 5 afternoons at home on school days, while there is also a caregiver present to offer the vegetables;
- Both caregivers as well as the child are willing to comply to the study procedure;
Key exclusion criteria (2 listed)
- Children who have any allergies or intolerances to the fruits and vegetables used in the study;
- Not willing to eat the test foods because of eating habits or beliefs as indicated by parent or caregiver;
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 |
|---|---|---|
| Vegetable varietyEither children are offered a variety of three vegetables or a single vegetable. | Behavioural | All subjects |
| Vegetable offering strategyEither children can decide when to eat their vegetables or parents initiate a moment. | Behavioural | All subjects |
Primary outcome
consumption during the measurement afternoons
Time frame: 8 afternoons as chosen by the participant
Consumption during each of the measurement afternoons is measured using the SnackBox. The SnackBox assumes consumption when decreases in weight are detected. To assess the effect of both offering strategies and there interaction, a two-way ANOVA is conducted.
1 secondary outcome
true consumption
Time frame: 8 afternoons as chosen by the participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 41314343de Gooijer FJ, Camps G, Feskens EJM, Lasschuijt M. The impact of variety and free accessibility of snack vegetables on the intake of 3- to 7-year-old children: A randomized cross-over trial. Appetite. 2026 Mar 1;218:108392. doi: 10.1016/j.appet.2025.108392. Epub 2025 Nov 26.
- 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.
Marlou L Lasschuijt, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetable variety and Vegetable offering strategy in people with Nutrition, Healthy, run by Wageningen University at 1 site in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Femke Gooijer, MSc (+31612156023, femke.degooijer@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption during the measurement afternoons (time frame: 8 afternoons as chosen by the participant). 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 NCT06212375, which also lists 1 linked publication.
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 18 Jan 2024.