- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348176
Baby's First Bites: Promoting Vegetable Intake in Infants and Toddlers
November 16, 2020 updated by: Judi Mesman, Universiteit Leiden
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
255
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Leiden, Netherlands, 2300 RB
- Leiden University, Faculty of Social Sciences, Education and Child Studies
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Wageningen, Netherlands, 6708WE
- Wageningen University, Department of Agrotechnology and Food Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vegetable exposure
Repeated exposure to a variety of vegetables from the start of complementary feeding
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Repeated exposure to variety of vegetables
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Experimental: VIPP-Feeding Infants
Promotion of responsive feeding practices from the start of complementary feeding
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Promoting responsive feeding practices
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Experimental: Exposure + VIPP-FI
Combination of repeated exposure to vegetables and promotion of responsive feeding practices
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Repeated exposure to variety of vegetables
Promoting responsive feeding practices
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Sham Comparator: Control
Phone calls on development child with no information on complementary feeding
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Phone calls with mother about development of child, no advice on complementary feeding
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Intake of vegetables as measured by 3 days of 24hr recall electronic diaries (using the Compl-eat system developed at Wageningen University)
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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
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)
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Liking of vegetables as measured by questionnaire (Barends et al., 2013)
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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)
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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
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Measured at child age of 18 months
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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)
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Measured by the Child Eating Behavior Questionnaire
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child eating behavior
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 with the Child Eating Behavior Questionnaire
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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)
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Change in child anthropometrics
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)
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Height and weight of child combined to report zBMI
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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)
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Change in self-reported maternal feeding style
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)
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Measured with Infant Feeding Style Questionnaire
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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)
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Change in observed maternal feeding style
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)
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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
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judi Mesman, PhD, Leiden University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2016
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
November 17, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 057-14-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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