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

• ClinicalTrials.gov Identifier: NCT03348176
• Recruitment Status: Completed
• First Posted: November 20, 2017
• Last Update Posted: November 17, 2020
• Sponsor: Universiteit Leiden
• Collaborators: Wageningen University; Danone Research; Nutricia, Inc.
• Information provided by (Responsible Party): Judi Mesman, Universiteit Leiden

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.

Condition or disease	Intervention/treatment	Phase
Vegetable Acceptance in Early Childhood; Childhood Obesity; Childhood Overweight	Other: Vegetable exposure; Behavioral: VIPP-Feeding Infants; Other: Control	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 255 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Investigator)
• Masking Description: Investigators coding parental outcome measures of the study from videomaterial are masked for study-arm
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 11, 2016
• Actual Primary Completion Date: June 2020
• Actual Study Completion Date: June 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vegetable exposure; Repeated exposure to a variety of vegetables from the start of complementary feeding	Other: Vegetable exposure; Repeated exposure to variety of vegetables
Experimental: VIPP-Feeding Infants; Promotion of responsive feeding practices from the start of complementary feeding	Behavioral: VIPP-Feeding Infants; Promoting responsive feeding practices
Experimental: Exposure + VIPP-FI; Combination of repeated exposure to vegetables and promotion of responsive feeding practices	Other: Vegetable exposure; Repeated exposure to variety of vegetables; Behavioral: VIPP-Feeding Infants; Promoting responsive feeding practices
Sham Comparator: Control; Phone calls on development child with no information on complementary feeding	Other: Control; Phone calls with mother about development of child, no advice on complementary feeding

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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)
3. 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
4. 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 Outcome Measures :

1. 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
2. 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) ]
   Height and weight of child combined to report zBMI
3. 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) ]
   Measured with Infant Feeding Style Questionnaire
4. 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) ]
   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

Eligibility Criteria

• Ages Eligible for Study: 4 Months to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Netherlands

Leiden University, Faculty of Social Sciences, Education and Child Studies

Leiden, Netherlands, 2300 RB

Wageningen University, Department of Agrotechnology and Food Sciences

Wageningen, Netherlands, 6708WE

Sponsors and Collaborators

Universiteit Leiden

Wageningen University

Danone Research

Nutricia, Inc.

Investigators

• Principal Investigator: Judi Mesman, PhD; Leiden University

More Information

Additional Information:

Trial website, including participant information and possibility to enroll 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Judi Mesman, Prof. dr. J. Mesman, Universiteit Leiden
• ClinicalTrials.gov Identifier: NCT03348176
• Other Study ID Numbers: 057-14-002
• First Posted: November 20, 2017
• Last Update Posted: November 17, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pediatric Obesity; Overweight; Body Weight; Obesity; Overnutrition; Nutrition Disorders