NCT03348176

Brief Summary

Overweight and obesity in preschool children is more and more common and predicts overweight in later childhood and adulthood. A healthy eating pattern with many vegetables decreases the risk to develop overweight. As many food preferences are learned in the first years of life, teaching children to like vegetables from the very start of eating solid foods is essential. Starting baby's first bites of solid foods with vegetables instead of more sweet tastes like fruits may promote vegetable liking. Also, it is important that parents know how to feed their children: e.g., paying attention to whether the child is hungry or full is essential, as is not pressuring them to eat. What is yet unknown is which of these two are more important to promote, to facilitate vegetable liking in young children. Is starting with vegetables most important, or educating parents on their feeding-techniques? And is a combination of both most effective? This study tests which of three interventions is most effective to promote vegetable intake and liking in children up until the age of 3 years: a) a focus on the 'what' (starting with vegetables); b) a focus on the 'how' (listen to your child's cues while feeding); c) a focus on both the 'what' and the 'how'. These three groups will be compared to a control group receiving no advice on how to introduce solid foods on children's vegetable intake and liking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

4.1 years

First QC Date

November 9, 2017

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in vegetable intake

    Intake of vegetables as measured by 3 days of 24hr recall electronic diaries (using the Compl-eat system developed at Wageningen University)

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

  • Change in vegetable liking

    Liking of vegetables as measured by questionnaire (Barends et al., 2013)

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

  • Child self-regulation of energy intake

    Measured experimentally; protocol designed for this study. In essence, children eat a meal at home until they are full, and after a short break are offered a variety of snacks. How much of the snacks they eat is a measure of child self-regulation of energy intake

    Measured at child age of 18 months

  • Change in child self-regulation of energy intake

    Measured by the Child Eating Behavior Questionnaire

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

Secondary Outcomes (4)

  • Change in child eating behavior

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

  • Change in child anthropometrics

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

  • Change in self-reported maternal feeding style

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

  • Change in observed maternal feeding style

    Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)

Study Arms (4)

Vegetable exposure

EXPERIMENTAL

Repeated exposure to a variety of vegetables from the start of complementary feeding

Other: Vegetable exposure

VIPP-Feeding Infants

EXPERIMENTAL

Promotion of responsive feeding practices from the start of complementary feeding

Behavioral: VIPP-Feeding Infants

Exposure + VIPP-FI

EXPERIMENTAL

Combination of repeated exposure to vegetables and promotion of responsive feeding practices

Other: Vegetable exposureBehavioral: VIPP-Feeding Infants

Control

SHAM COMPARATOR

Phone calls on development child with no information on complementary feeding

Other: Control

Interventions

Repeated exposure to variety of vegetables

Exposure + VIPP-FIVegetable exposure

Promoting responsive feeding practices

Exposure + VIPP-FIVIPP-Feeding Infants
ControlOTHER

Phone calls with mother about development of child, no advice on complementary feeding

Control

Eligibility Criteria

Age4 Months - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • First-time mothers of healthy term infants who report to have good reading and writing skills in the Dutch language

You may not qualify if:

  • Medical problems in the infant that influence the ability to eat
  • Major psychiatric problems in the mother, like depression
  • Mothers who are not willing to start weaning exclusively with prepared vegetable/fruit purees from the Nutricia brand
  • Mothers who are not willing for themselves and/or their infants to be video-taped

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University, Faculty of Social Sciences, Education and Child Studies

Leiden, 2300 RB, Netherlands

Location

Wageningen University, Department of Agrotechnology and Food Sciences

Wageningen, 6708WE, Netherlands

Location

Related Publications (3)

  • Mueller C, Mars M, Zeinstra GG, Perenboom C, Forde CG, Jager G. Sowing the Seeds of Taste? A Novel Approach to Investigate the Impact of Early Sweet Exposure on Children's Dietary Taste Patterns from 12 to 36 Mo. J Nutr. 2025 May;155(5):1466-1473. doi: 10.1016/j.tjnut.2025.03.017. Epub 2025 Mar 18.

  • van Vliet MS, Schultink JM, Jager G, de Vries JHM, Mesman J, de Graaf C, Vereijken CMJL, Weenen H, de Wild VWT, Martens VEG, Houniet H, van der Veek SMC. The Baby's First Bites RCT: Evaluating a Vegetable-Exposure and a Sensitive-Feeding Intervention in Terms of Child Health Outcomes and Maternal Feeding Behavior During Toddlerhood. J Nutr. 2022 Feb 8;152(2):386-398. doi: 10.1093/jn/nxab387.

  • van der Veek SMC, de Graaf C, de Vries JHM, Jager G, Vereijken CMJL, Weenen H, van Winden N, van Vliet MS, Schultink JM, de Wild VWT, Janssen S, Mesman J. Baby's first bites: a randomized controlled trial to assess the effects of vegetable-exposure and sensitive feeding on vegetable acceptance, eating behavior and weight gain in infants and toddlers. BMC Pediatr. 2019 Aug 1;19(1):266. doi: 10.1186/s12887-019-1627-z.

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Judi Mesman, PhD

    Leiden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators coding parental outcome measures of the study from videomaterial are masked for study-arm
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. J. Mesman

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 20, 2017

Study Start

May 11, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations