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Clinical Trials/NCT03348176
NCT03348176CompletedNot Applicable

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

Universiteit Leiden2 sites in 1 country255 target enrollmentStarted: May 11, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
255
Locations
2
Primary Endpoint
Change in vegetable liking

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Single (Investigator)

Masking Description

Investigators coding parental outcome measures of the study from videomaterial are masked for study-arm

Eligibility Criteria

Ages
4 Months to 3 Years (Child)
Sex
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

Arms & Interventions

Vegetable exposure

Experimental

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

Intervention: Vegetable exposure (Other)

VIPP-Feeding Infants

Experimental

Promotion of responsive feeding practices from the start of complementary feeding

Intervention: VIPP-Feeding Infants (Behavioral)

Exposure + VIPP-FI

Experimental

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

Intervention: Vegetable exposure (Other)

Exposure + VIPP-FI

Experimental

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

Intervention: VIPP-Feeding Infants (Behavioral)

Control

Sham Comparator

Phone calls on development child with no information on complementary feeding

Intervention: Control (Other)

Outcomes

Primary Outcomes

Change in vegetable liking

Time Frame: 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)

Child self-regulation of energy intake

Time Frame: 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

Change in vegetable intake

Time Frame: 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)

Change in child self-regulation of energy intake

Time Frame: 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 Outcomes

  • 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 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))
  • 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 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Judi Mesman

Prof. dr. J. Mesman

Universiteit Leiden

Study Sites (2)

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