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

Primary Purpose

Vegetable Acceptance in Early Childhood, Childhood Obesity, Childhood Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vegetable exposure
VIPP-Feeding Infants
Control
Sponsored by
Universiteit Leiden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vegetable Acceptance in Early Childhood

Eligibility Criteria

4 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Leiden University, Faculty of Social Sciences, Education and Child Studies
  • Wageningen University, Department of Agrotechnology and Food Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Vegetable exposure

VIPP-Feeding Infants

Exposure + VIPP-FI

Control

Arm Description

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

Promotion of responsive feeding practices from the start of complementary feeding

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

Phone calls on development child with no information on complementary feeding

Outcomes

Primary Outcome Measures

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)
Change in vegetable liking
Liking of vegetables as measured by questionnaire (Barends et al., 2013)
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
Change in child self-regulation of energy intake
Measured by the Child Eating Behavior Questionnaire

Secondary Outcome Measures

Change in child eating behavior
Measured with the Child Eating Behavior Questionnaire
Change in child anthropometrics
Height and weight of child combined to report zBMI
Change in self-reported maternal feeding style
Measured with Infant Feeding Style Questionnaire
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

Full Information

First Posted
November 9, 2017
Last Updated
November 16, 2020
Sponsor
Universiteit Leiden
Collaborators
Wageningen University, Danone Research, Nutricia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03348176
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Leiden
Collaborators
Wageningen University, Danone Research, Nutricia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetable Acceptance in Early Childhood, Childhood Obesity, Childhood Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Masking Description
Investigators coding parental outcome measures of the study from videomaterial are masked for study-arm
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegetable exposure
Arm Type
Experimental
Arm Description
Repeated exposure to a variety of vegetables from the start of complementary feeding
Arm Title
VIPP-Feeding Infants
Arm Type
Experimental
Arm Description
Promotion of responsive feeding practices from the start of complementary feeding
Arm Title
Exposure + VIPP-FI
Arm Type
Experimental
Arm Description
Combination of repeated exposure to vegetables and promotion of responsive feeding practices
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Phone calls on development child with no information on complementary feeding
Intervention Type
Other
Intervention Name(s)
Vegetable exposure
Intervention Description
Repeated exposure to variety of vegetables
Intervention Type
Behavioral
Intervention Name(s)
VIPP-Feeding Infants
Intervention Description
Promoting responsive feeding practices
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Phone calls with mother about development of child, no advice on complementary feeding
Primary Outcome Measure Information:
Title
Change in vegetable intake
Description
Intake of vegetables as measured by 3 days of 24hr recall electronic diaries (using the Compl-eat system developed at Wageningen University)
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)
Title
Change in vegetable liking
Description
Liking of vegetables as measured by questionnaire (Barends et al., 2013)
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)
Title
Child self-regulation of energy intake
Description
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
Time Frame
Measured at child age of 18 months
Title
Change in child self-regulation of energy intake
Description
Measured by the Child Eating Behavior Questionnaire
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)
Secondary Outcome Measure Information:
Title
Change in child eating behavior
Description
Measured with the Child Eating Behavior Questionnaire
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)
Title
Change in child anthropometrics
Description
Height and weight of child combined to report zBMI
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)
Title
Change in self-reported maternal feeding style
Description
Measured with Infant Feeding Style Questionnaire
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)
Title
Change in observed maternal feeding style
Description
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judi Mesman, PhD
Organizational Affiliation
Leiden University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University, Faculty of Social Sciences, Education and Child Studies
City
Leiden
ZIP/Postal Code
2300 RB
Country
Netherlands
Facility Name
Wageningen University, Department of Agrotechnology and Food Sciences
City
Wageningen
ZIP/Postal Code
6708WE
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34791320
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.
Results Reference
derived
PubMed Identifier
31370830
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.
Results Reference
derived
Links:
URL
http://babyseerstehapjes.nl/
Description
Trial website, including participant information and possibility to enroll

Learn more about this trial

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

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