Fruit and Vegetable Intake in Preschoolers

NCT ID: NCT05730530

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2023-08-01

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.

Conditions

Children, Only; Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Classroom assigned to receive the 6-week long nutrition education curriculum

Group Type: EXPERIMENTAL

Nutrition education curriculum

Intervention Type: BEHAVIORAL

This intervention consists of a 6-week-long nutrition education curriculum aimed at improving fruit and vegetable acceptance and consumption. Sessions will occur within the classroom 3 times per week for 6 weeks. Each week, the sessions will consist of 2 days of teaching activities and 1 day of taste-test activities designed for children to guess various common fruits and vegetables, assemble recipes including 2-4 different fruits and vegetables, and then taste the foods. These activities will be conducted in a full-classroom group setting.

Control

Classroom assigned to receive no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrition education curriculum

This intervention consists of a 6-week-long nutrition education curriculum aimed at improving fruit and vegetable acceptance and consumption. Sessions will occur within the classroom 3 times per week for 6 weeks. Each week, the sessions will consist of 2 days of teaching activities and 1 day of taste-test activities designed for children to guess various common fruits and vegetables, assemble recipes including 2-4 different fruits and vegetables, and then taste the foods. These activities will be conducted in a full-classroom group setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Food Allergies
• Taking medications
• Developmental delays

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sibylle Kranz, PhD, RDN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibylle Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Westminster Child Care Center

Charlottesville, Virginia, United States

Countries

United States

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Other Identifiers

SBS 5304

Identifier Type: -

Identifier Source: org_study_id