Vegetable Acceptance in Early ChildhoodNCT03348176
Baby's First Bites: Promoting Vegetable Intake in Infants and Toddlers
A study testing Vegetable exposure and VIPP-Feeding Infants in people with Vegetable Acceptance in Early Childhood and Childhood Obesity, run by Universiteit Leiden at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 4 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegetable Acceptance in Early Childhood, Childhood Obesity, Childhood Overweight
- What is being tested?
- Vegetable exposure and VIPP-Feeding Infants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 May 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First-time mothers of healthy term infants who report to have good reading and writing skills in the Dutch language
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University, Faculty of Social Sciences, Education and Child Studies
Leiden, 2300 RB
Wageningen University, Department of Agrotechnology and Food Sciences
Wageningen, 6708WE
About this study
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
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.
Read the 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.
- Being tested
- Vegetable exposure, VIPP-Feeding Infants, Control
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable exposureOther
Repeated exposure to variety of vegetables
VIPP-Feeding InfantsBehavioural
Promoting responsive feeding practices
ControlOther
Phone calls with mother about development of child, no advice on complementary feeding
| Study group | Role | What they receive |
|---|---|---|
| Vegetable exposure | Experimental | Repeated exposure to a variety of vegetables from the start of complementary feeding Receives: Other: Vegetable exposure |
| VIPP-Feeding Infants | Experimental | Promotion of responsive feeding practices from the start of complementary feeding Receives: Behavioral: VIPP-Feeding Infants |
| Exposure + VIPP-FI | Experimental | Combination of repeated exposure to vegetables and promotion of responsive feeding practices Receives: Other: Vegetable exposure; Behavioral: VIPP-Feeding Infants |
| Control | Sham comparator | Phone calls on development child with no information on complementary feeding Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
Liking of vegetables as measured by questionnaire (Barends et al., 2013)
Measured: 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)
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: Measured at child age of 18 months
Change in child self-regulation of energy intake
Measured by the Child Eating Behavior Questionnaire
Measured: 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 (4)
Change in child eating behavior
Measured with the Child Eating Behavior Questionnaire
Measured: 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 anthropometrics
Height and weight of child combined to report zBMI
Measured: 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 with Infant Feeding Style Questionnaire
Measured: 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
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: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start11 May 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vegetable Acceptance in Early ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University, Danone Global Research & Innovation Center, Nutricia, Inc.
- Responsible party
- Principal investigator, Judi Mesman, Universiteit Leiden
- Investigators
- Judi Mesman, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348176
- Sponsor's protocol ID
- 057-14-002
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller C, Mars M, Zeinstra GG, Perenboom C, Forde CG, Jager G. Sowing the Seeds of Taste? A Novel Approach to Investigate the Impact of Early Sweet Exposure on Children's Dietary Taste Patterns from 12 to 36 Mo. J Nutr. 2025 May;155(5):1466-1473. doi: 10.1016/j.tjnut.2025.03.017. Epub 2025 Mar 18.
PubMed 40113172van 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.
PubMed 34791320van 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.
PubMed 31370830
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03348176
- Acronym / sponsor ID
- 057-14-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- Wageningen University, Danone Global Research & Innovation Center, Nutricia, Inc.
- Study start
- 11 May 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vegetable exposure | Experimental | Other: Vegetable exposureRepeated exposure to a variety of vegetables from the start of complementary feeding |
| VIPP-Feeding Infants | Experimental | Behavioral: VIPP-Feeding InfantsPromotion of responsive feeding practices from the start of complementary feeding |
| Exposure + VIPP-FI | Experimental | Other: Vegetable exposure, Behavioral: VIPP-Feeding InfantsCombination of repeated exposure to vegetables and promotion of responsive feeding practices |
| Control | Sham comparator | Other: ControlPhone calls on development child with no information on complementary feeding |
Who may qualify
- Ages
- 4 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First-time mothers of healthy term infants who report to have good reading and writing skills in the Dutch language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetable exposureRepeated exposure to variety of vegetables | Other | Exposure + VIPP-FI, Vegetable exposure |
| VIPP-Feeding InfantsPromoting responsive feeding practices | Behavioural | Exposure + VIPP-FI, VIPP-Feeding Infants |
| ControlPhone calls with mother about development of child, no advice on complementary feeding | Other | Control |
Primary outcome
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 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 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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 40113172Mueller C, Mars M, Zeinstra GG, Perenboom C, Forde CG, Jager G. Sowing the Seeds of Taste? A Novel Approach to Investigate the Impact of Early Sweet Exposure on Children's Dietary Taste Patterns from 12 to 36 Mo. J Nutr. 2025 May;155(5):1466-1473. doi: 10.1016/j.tjnut.2025.03.017. Epub 2025 Mar 18.
- Derived from this study: PubMed 34791320van 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.
- Derived from this study: PubMed 31370830van 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.
- Trial website, including participant information and possibility to enrollLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Vegetable Acceptance in Early Childhood
Active, not recruiting
Evaluating the Implementation and Impact of an Enhanced SNAP-Ed Delivered Curriculum in Low-income Preschools
Vegetable Acceptance in Early Childhood, Vegetable Intake
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judi Mesman, PhD principal investigator
Leiden University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetable exposure and VIPP-Feeding Infants in people with Vegetable Acceptance in Early Childhood and Childhood Obesity, run by Universiteit Leiden at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348176, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.