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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348176
• Other study ID #: 057-14-002
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: Universiteit Leiden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Childhood Overweight
• Overweight
• Pediatric Obesity
• Vegetable Acceptance in Early Childhood

Intervention

Other:
• Vegetable exposure
Repeated exposure to variety of vegetables

Behavioral:
• VIPP-Feeding Infants
Promoting responsive feeding practices

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

Locations

Country	Name	City	State
Netherlands	Leiden University, Faculty of Social Sciences, Education and Child Studies	Leiden
Netherlands	Wageningen University, Department of Agrotechnology and Food Sciences	Wageningen

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Leiden	Danone Research, Nutricia, Inc., Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	Change in child eating behavior	Measured with 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	Change in child anthropometrics	Height and weight of child combined to report zBMI	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	Change in self-reported maternal feeding style	Measured with Infant Feeding Style 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	Change in observed maternal feeding style	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	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)

External Links

•   Trial website, including participant information and possibility to enroll