CompletedNot Applicable

Fruit and Vegetable Intake in Preschoolers

United States19 participantsStarted 2023-02-14

Plain-language summary

The goal of this randomized controlled trial is to examine fruit and vegetable consumption in preschoolers following a nutrition education curriculum. The main questions it aims to answer is: 1. Is this intervention consisting of nutrition education and taste-test activities able to improve fruit and vegetable consumption in preschoolers during their usual lunch meal? 2. Is the improvement of fruit and vegetable consumption sustained for at least 6 weeks after completion of the intervention? Participants in the intervention classroom will partake in 3 nutrition education sessions per week during the 6-week-long curriculum. Researchers will compare this to changes in fruit and vegetable intake of the children in the control classroom, who will undergo identical measurements, but will not participate in the curriculum.

Who can participate

Age range

3 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Typically-developing children with no food allergies and not taking medication Exclusion Criteria: * Food Allergies * Taking medications * Developmental delays

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fruit and vegetable intake post-intervention

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)

Fruit and vegetable intake at follow-up

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)

Skin carotenoid levels post-intervention

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)

Skin carotenoid levels at follow-up

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)

Trial details

NCT IDNCT05730530

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-30

View on ClinicalTrials.gov More Children, Only trials

Plain-language summary

Who can participate

Age range

3 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Typically-developing children with no food allergies and not taking medication Exclusion Criteria: * Food Allergies * Taking medications * Developmental delays

What they're measuring

Fruit and vegetable intake post-intervention

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)

Fruit and vegetable intake at follow-up

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)

Skin carotenoid levels post-intervention

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)

Skin carotenoid levels at follow-up

Timeframe: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)