Clinical trial NCT03348176: Baby's First Bites: Promoting Vegetable Intake in Infants and Toddlers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetable Acceptance in Early Childhood
Childhood Obesity
Childhood Overweight
Lead sponsor: Universiteit Leiden
Sponsor class: OTHER
Collaborators: name: Wageningen University
name: Danone Global Research & Innovation Center
name: Nutricia, Inc.
First posted: 2017-11-20
Enrollment: 255
Sex: ALL
Minimum age (years): 4
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in vegetable intake
timeFrame: 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)
measure: Change in vegetable liking
timeFrame: 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)
measure: Child self-regulation of energy intake
timeFrame: Measured at child age of 18 months
measure: Change in child self-regulation of energy intake
timeFrame: 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:
measure: Change in child eating behavior
timeFrame: 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)
measure: Change in child anthropometrics
timeFrame: 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)
measure: Change in self-reported maternal feeding style
timeFrame: 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)
measure: Change in observed maternal feeding style
timeFrame: 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)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University, Faculty of Social Sciences, Education and Child Studies
city: Wageningen
country: Netherlands
facility: Wageningen University, Department of Agrotechnology and Food Sciences
Study officials:
affiliation: Leiden University
name: Judi Mesman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.