Vegetable Offering in the Home Environment - Impact of Free Accessibility and Choice on Snack Vegetable Intake (VOHE)

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Behavioral: Vegetable variety; Behavioral: Vegetable offering strategy

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Femke Gooijer, MSc; Phone Number: +31612156023; Email: femke.degooijer@wur.nl
• Study Contact Backup: Name: Marlou L Lasschuijt, PhD; Email: marlou.lasschuijt@wur.nl

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WE
      • Recruiting
      • Wageningen University and Research
      • Contact: Guido Camps, PhD; Email: guido.camps@wur.nl
      • Contact: Femke J de Gooijer, MSc; Phone Number: +31612156023; Email: femke.degooijer@wur.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; Within subject study design: All children receive the four possible combinations of interventions.	Behavioral: Vegetable variety; Either children are offered a variety of three vegetables or a single vegetable.; Behavioral: Vegetable offering strategy; Either children can decide when to eat their vegetables or parents initiate a moment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 afternoons as chosen by the participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 afternoons as chosen by the participant

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: OnePlanet Research Center Wageningen

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VOHEStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No