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临床试验/NCT03348176
NCT03348176已完成不适用

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 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2016年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
2
主要终点
Change in vegetable liking

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

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

入排标准

年龄范围
4 Months 至 3 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •First-time mothers of healthy term infants who report to have good reading and writing skills in the Dutch language

排除标准

  • •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

研究组 & 干预措施

Vegetable exposure

Experimental

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

干预措施: Vegetable exposure (Other)

VIPP-Feeding Infants

Experimental

Promotion of responsive feeding practices from the start of complementary feeding

干预措施: VIPP-Feeding Infants (Behavioral)

Exposure + VIPP-FI

Experimental

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

干预措施: Vegetable exposure (Other)

Exposure + VIPP-FI

Experimental

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

干预措施: VIPP-Feeding Infants (Behavioral)

Control

Sham Comparator

Phone calls on development child with no information on complementary feeding

干预措施: Control (Other)

结局指标

主要结局

Change in vegetable liking

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judi Mesman

Prof. dr. J. Mesman

Universiteit Leiden

研究点 (2)

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