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临床试验/NCT02266953
NCT02266953已完成不适用

The Use of a Communication Tool About Diet in Public Health Nurse Consultations at the Child Health Centre When the Child is Aged 10 Months to 2 Years

Oslo Metropolitan University2 个研究点 分布在 1 个国家目标入组 686 人开始时间: 2015年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
686
试验地点
2
主要终点
Increase in the daily intake of vegetables

研究概览

简要总结

The purpose of this study is to promote optimal nutrition for the child based on the public health nurse's family-focused conversations at the child health centre. An image based communication tool is used in an intervention in order to promote dialogue and active participation by the parents about themes concerning food and feeding practices.

详细描述

Norway, as other Nordic countries, has a long-standing tradition of extensive and freely available health care for children under school age at the child health centre. Virtually all parents with small children use these child health centres, having regular encounters with public health nurses. This service aims at promoting health and preventing disease in the population. However, when comes to content and performance of conversation about food and feeding practices there are no guidelines regarding how to adapt the information to the individual child and to his or her family after infancy and up to two years of age.

The overall purpose of this study is to promote optimal nutrition for the child based on the public health nurse's family-focused conversations at the child health centre.

The design of the study is a cluster randomized controlled trial. Statistics Norway has on the basis of a systematic match drawn samples of five pairs of municipalities in Norway. It is random which municipality in each match is extracted respectively to intervention or control municipality.

Public health nurses on child health centres within intervention municipalities will use a communication tool about food and feeding practices in their encounters with participating children and parents when the child is 10-, 12- and 15-18 months old. In the control municipalities corresponding encounters will be as usual, without use of the actual communication tool. The parents will answer a food frequency questionnaire on behalf of their child when the child is 10 months old (baseline) and at the age of two years (final measurement).

Sample size consideration: The aim of the study is to reveal change in vegetable intake. The investigators keep level of statistical significance at the customary 5 % and statistical power of 80 % (beta equal to 20 %), the investigators would need 176 children in each group to reveal the change described above as statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • All parents and their children, regardless of the parents' country of origin or native language, who visit the child health centre when the particular child is six months old.
  • Parents that perceive themselves to have sufficient knowledge of Norwegian language to understand the information sheet in Norwegian about the study.

排除标准

  • Parents and their children who do not visit the child health centre when the particular child is six months old.
  • Parents who do not experience to have sufficient knowledge of Norwegian to read and understand the written Norwegian information about the study.
  • The youngest twin and the midst and youngest triplet if the child is a twin or triplet.

结局指标

主要结局

Increase in the daily intake of vegetables

时间窗: An expected average of 14 months from baseline

Metrics are based on parents answering Food Frequency Questionnaires (FFQs) on behalf of their child, at baseline and at endpoint. In addition to questions about the child's diet, there are questions about the child's weight and length at birth, six months, 10 months and 2 years. Both FFQs are updated versions, based on validated and standardized FFQs used in earlier national dietary surveys among infants and toddlers in Norway, conducted under the auspices of the University of Oslo, the Norwegian Food Safety Authority and the Norwegian Ministry of Health and Care Services (Spedkost \[Infant Diet\] 2006-2007 (IS-1635); Småbarnskost \[Toddler Diet\] 2007 (IS-1731)). Analyses of the data will be conducted by use of a diet calculation system. The expectation is an increased intake of 15 g vegetables daily, based on average intake of vegetables of 50 g daily at the age of 1 year according to Spedkost \[Infant Diet\] 2006-2007 (IS-1635) and Småbarnskost \[Toddler Diet\]2007 (IS-1731).

次要结局

  • Decreased proportion of saturated fat consumed daily(An expected average of 14 months from baseline)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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