NCT06212375

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 8, 2024

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • true consumption

    8 afternoons as chosen by the participant

Study Arms (1)

All subjects

EXPERIMENTAL

Within subject study design: All children receive the four possible combinations of interventions.

Behavioral: Vegetable varietyBehavioral: Vegetable offering strategy

Interventions

Either children are offered a variety of three vegetables or a single vegetable.

All subjects

Either children can decide when to eat their vegetables or parents initiate a moment.

All subjects

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708 WE, Netherlands

RECRUITING

Central Study Contacts

Femke Gooijer, MSc

CONTACT

Marlou L Lasschuijt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Marlou Lasscuijt

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

October 17, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations