Baby's First Bites: Promoting Vegetable Intake in Infants and Toddlers

Sponsor
Universiteit Leiden (Other)
Overall Status
Completed
CT.gov ID
NCT03348176
Collaborator
Wageningen University (Other), Danone Research (Industry), Nutricia, Inc. (Industry)
255
2
4
48.7
127.5
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vegetable exposure
  • Behavioral: VIPP-Feeding Infants
  • Other: Control
N/A

Detailed Description

The weaning period in infancy is an important time for introducing healthy eating patterns that include vegetables to protect children against the development of overweight. There is evidence that it is important what weaning infants are offered: starting exclusively with vegetables is more successful for the promotion of vegetable acceptance than starting with fruits. There is also evidence that it is important how infants are weaned: responsive feeding characterised by sensitive responses to infant cues during feeding fosters healthy eating. However, the what and the how of infant weaning have never been experimentally tested in the same study to determine their relative importance for fostering vegetable acceptance, nor have they been combined to test whether a focus on both may be superior to each approach separately. This study employs a randomised controlled design testing the effectiveness of (a) a focus on the what in weaning, i.e., a vegetable-exposure intervention; (b) a focus on the how in weaning, i.e., an intervention to enhance responsive feeding; (c) a combined focus on what and how in weaning in an integrated intervention; (d) an attention-control group. Vegetable acceptance will be measured before and directly after the interventions when the child is 18 months of age, and when the child is 24 and 36 months of age. The proposed study is based on a unique integration of expert knowledge from the field of nutrition and the field of parenting, which will provide new insights into the mechanisms underlying the development of vegetable acceptance in infants, and ultimately the prevention of overweight.

Study Design

Study Type:
Interventional
Actual Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Masking Description:
Investigators coding parental outcome measures of the study from videomaterial are masked for study-arm
Primary Purpose:
Prevention
Official Title:
The What and How in Weaning: A Randomized Controlled Trial to Assess the Effects of Vegetable-exposure and Responsive Feeding on Vegetable Acceptance in Infants and Toddlers
Actual Study Start Date :
May 11, 2016
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vegetable exposure

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

Other: Vegetable exposure
Repeated exposure to variety of vegetables

Experimental: VIPP-Feeding Infants

Promotion of responsive feeding practices from the start of complementary feeding

Behavioral: VIPP-Feeding Infants
Promoting responsive feeding practices

Experimental: Exposure + VIPP-FI

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

Other: Vegetable exposure
Repeated exposure to variety of vegetables

Behavioral: VIPP-Feeding Infants
Promoting responsive feeding practices

Sham Comparator: Control

Phone calls on development child with no information on complementary feeding

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

Outcome Measures

Primary Outcome Measures

  1. Change in vegetable intake [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)]

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

  2. Change in vegetable liking [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)]

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

  3. Child self-regulation of energy intake [Measured at child age of 18 months]

    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

  4. Change in child self-regulation of energy intake [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)]

    Measured by the Child Eating Behavior Questionnaire

Secondary Outcome Measures

  1. 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)]

    Measured with the Child Eating Behavior Questionnaire

  2. 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)]

    Height and weight of child combined to report zBMI

  3. 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)]

    Measured with Infant Feeding Style Questionnaire

  4. 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)]

    Observed during family meals with an observation scale based on the Responsiveness to Child Feeding Cues Scale (Hodges et al.). Maternal responsiveness to child hunger cues (scale range 1 (very unresponsive) - 5 (very responsive); higher score is better) and pacing (scale range 1 ((almost) never adequate - 5 (almost) Always adequate; higher score is better) will be coded

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Months to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leiden University, Faculty of Social Sciences, Education and Child Studies Leiden Netherlands 2300 RB
2 Wageningen University, Department of Agrotechnology and Food Sciences Wageningen Netherlands 6708WE

Sponsors and Collaborators

  • Universiteit Leiden
  • Wageningen University
  • Danone Research
  • Nutricia, Inc.

Investigators

  • Principal Investigator: Judi Mesman, PhD, Leiden University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Judi Mesman, Prof. dr. J. Mesman, Universiteit Leiden
ClinicalTrials.gov Identifier:
NCT03348176
Other Study ID Numbers:
  • 057-14-002
First Posted:
Nov 20, 2017
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2020