Clinical trial NCT05730530: Fruit and Vegetable Intake in Preschoolers
Official title: Nutrition Education Intervention to Improve Fruit and Vegetable Consumption in Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Only
Nutrition, Healthy
Keywords: Preschool
Fruits and vegetables
Nutrition education
Behavior change theory
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group-randomized trial with individual-level outcomes
Primary purpose: PREVENTION

Brief 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.

Detailed description: Fruit and vegetable consumption in preschoolers in the United States is very low, with the majority of children not meeting the national recommendations. However, there is a lack of data indicating effective strategies to increase preschooler's fruit and vegetable intake and whether socio-demographic and eating behavior-related child characteristics (child eating behavior and relationship with food) may predict fruit and vegetable consumption in preschoolers as well as their response to the intervention. This information is important for researchers because it may allow for more effective development of future interventions that consider these potential external influences. There is also a lack of evidence-based interventions that are based on theoretical behavior change frameworks and the associated behavior change techniques. Furthermore, studies lack a long enough follow-up to measure whether any possibly observed behavior change (more fruits and vegetables consumed) in the preschoolers is maintained following the cessation of the intervention.

While fruit and vegetable consumption is associated with lower blood pressure in adults, little is known about this relationship in children. This will be examined in our study to determine if there is an association between blood pressure and fruit and vegetable intake at baseline and whether this association changes following the intervention.

To control for differences in energy needs, it is important to control for children's BMI-for-age percentile, which is calculated using their age, height, and weight. This is necessary because children who have higher BMI percentiles typically require more total energy consumption, which may influence fruit and vegetable consumption. Additionally, previous studies have observed that children with greater BMI percentile are less likely to eat adequate amounts of fruits and vegetables. However, this has not been measured in an interventional manner, and therefore it is unknown whether these associations are omnipotent, and whether they remain following a fruit and vegetable intervention. Therefore, our study will examine these relationships in a small sample of preschoolers to either support or contradict these previous observations.

In addition to measuring fruit and vegetable intake, it is also important to measure physical activity levels as a control variable for total energy requirements, as changes in physical activity levels may confound changes in dietary intake, including intake of fruits and vegetables. This is especially true of interventions that span different seasons (ie. winter and spring), as these may also influence physical activity levels and, subsequently, energy requirements. Secondarily, previous research has established an association between fruit and vegetable intake and both physical activity levels and screen time in children and adults. However, no studies have explored this relationship in preschool-aged children. Additionally, the evidence of the relationship between these two variables is limited to cross-sectional data; it is unknown whether an increase in one would influence the other. We plan to examine this in a small sample of preschoolers in an interventional setting.

Therefore, the purpose of this research is to determine whether such an intervention is able to increase and maintain fruit and vegetable intake during lunch in a sample of preschoolers, controlling for age, BMI percentile, and activity level. Additional aims are 1) to explore the relationship between fruit and vegetable intake and blood pressure, 2) examine the relationship between FV intake and physical activity levels in this sample of preschoolers, and 3) examine how BMI-percentile and socio-demographic and child- and parent-related eating-related characteristics are associated with fruit and vegetable intake. We plan to publish our findings in a scientific journal to contribute to the advancement of knowledge regarding interventions to improve fruit and vegetable intake in preschoolers, as information is evidently needed in this topic.

Eligibility criteria: Inclusion Criteria:

* Typically-developing children with no food allergies and not taking medication

Exclusion Criteria:

* Food Allergies
* Taking medications
* Developmental delays

Primary outcomes:
measure: Fruit and vegetable intake post-intervention
timeFrame: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
measure: Fruit and vegetable intake at follow-up
timeFrame: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
measure: Skin carotenoid levels post-intervention
timeFrame: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
measure: Skin carotenoid levels at follow-up
timeFrame: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
Secondary outcomes:
measure: Systolic and diastolic blood pressure, baseline
timeFrame: Baseline (week 0)
measure: Systolic and diastolic blood pressure, post-intervention
timeFrame: post-intervention (week 7)
measure: Systolic and diastolic blood pressure, follow-up
timeFrame: follow-up (week 14)
measure: Physical activity levels, baseline
timeFrame: Baseline (week 0)
measure: Physical activity levels, post-intervention
timeFrame: Post-intervention (week 7)
measure: Fruit and vegetable liking, baseline to post-intervention
timeFrame: Change in fruit and vegetable liking from baseline (week 0) to post-intervention (week 7)
measure: Fruit and vegetable liking, baseline to follow-up
timeFrame: Change in fruit and vegetable liking from baseline (week 0) to follow-up (week 14)
measure: Willingness to try fruit and vegetable
timeFrame: Once weekly during the taste-test activity of the nutrition education curriculum (6 weeks total; weeks 1-6)
measure: Satiety, baseline
timeFrame: Baseline (week 0)
measure: Satiety, post-intervention
timeFrame: post-intervention (week 7)
measure: Satiety, follow-up
timeFrame: follow-up (week 14)
measure: Anthropometrics
timeFrame: Baseline (week 0)
measure: Food intake during snack, baseline
timeFrame: Baseline (week 0)
measure: Food intake during snack, post-intervention
timeFrame: Post-intervention (week 7)
measure: Food intake at home, baseline
timeFrame: Baseline (week 0)
measure: Food intake at home, post-intervention
timeFrame: Post-intervention (week 7)
Other outcomes:
measure: Sociodemographic information
timeFrame: Baseline (week 0)
measure: Child eating behavior
timeFrame: Baseline (week 0)
Locations:
city: Charlottesville
country: United States
facility: Westminster Child Care Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sibylle Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
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