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临床试验/NCT02582554
NCT02582554已完成不适用

Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers

University of Guelph0 个研究点目标入组 166 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
166
主要终点
Score of Nutritional Risk as Assessed by the NutriSTEP Nutrition Knowledge Questionnaire

研究概览

简要总结

Good nutrition is necessary for optimal growth and development in young children. Nutrition risk screening can identify those at risk and to refer them for assessment and treatment. The NutriSTEP® (Nutrition Risk Screening for Every Preschooler) questionnaires are 17-item, community-based, parent-administered questionnaires for identifying nutritional risk in toddlers (18-35 months) and preschoolers (3-5 years). Internet versions are available on the Dietitians of Canada website as part of a Nutri-eSTEP online tool. NutriSTEP® is mandated for use in Ontario and New Brunswick and is also used in other provinces. NutriSTEP® has been implemented in Canadian jurisdictions and in research settings. Many health care practitioners, mainly registered dietitians, and policy makers, are asking for evidence that NutriSTEP® makes a difference and this project is proposed to show that nutrition screening with NutriSTEP® with its accompanying nutrition education resources will increase knowledge and change nutrition-related practices by parents of preschoolers.

This research will be a randomized control trial with more than 150 parents/caregivers of toddlers and preschoolers. The treatment group will receive screening with the Nutri-eSTEP version of NutriSTEP® and will receive the accompanying nutrition education messages and links to resources. A control group will receive the screening treatment at the end of a 12 week intervention. At the beginning and end of the 12 week period, parents/caregivers will fill out questionnaires on parental nutrition knowledge and nutrition-related behaviour (including attitudes and intentions).

This will be the first study of nutrition risk screening with NutriSTEP® to determine if the screening process, along with its accompanying nutrition education messages makes a difference.

详细描述

Study Design The proposed research will be a wait-listed randomized control trial of the efficacy of the NutriSTEP® screening process for toddlers and preschoolers. The treatment group will undergo screening with Nutri-eSTEP plus its accompanying nutrition education messages and links to resources. A control group will be wait-listed to receive the treatment (Nutri-eSTEP plus its accompanying nutrition education treatment) at the end of the intervention period.

Outcome variables Participants Parents/caregivers of toddlers and preschoolers will be recruited at various Ontario Early Years Centres (OEYCs) in southern Ontario.

Sample Size The sample size (http://www.stat.ubc.ca/) is estimated at 63 per group based on difference in scores on the NKQ of 2 (~half of the difference found between students and parents), with a SD of 4, alpha of 0.05 and statistical power of 0.80 (2-tailed). An allowance for 20% attrition (based on our previous test-retest reliability studies)(7,8,19) will see 77 participants per group recruited. This will also allow for enough power for an improvement in NutriSTEP® scores based on a difference of 2.2 units, standard deviation of 5, alpha of 0.05 and statistical power of 0.80 (1-tailed)(based on a difference in NutriSTEP® scores over 3 months of a parenting intervention study (56). The total sample of 154 will be recruited from ~20 OEYCs @ ~10 participants/site (based on previous experience).

Intervention NutriSTEP® Questionnaire: The toddler and preschool NutriSTEP® questionnaires will form part of the intervention for this trial.

Nutrition Education Material:

研究设计

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

入排标准

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

入选标准

  • Parents/caregivers of 3-5 year old children, speak English, read English at Grade 6 level

排除标准

  • Parent of an institutionalized child

结局指标

主要结局

Score of Nutritional Risk as Assessed by the NutriSTEP Nutrition Knowledge Questionnaire

时间窗: 12 weeks

A valid and reliable 40-item nutrition knowledge questionnaire has been developed to test the contents of the NutriSTEP questionnaire and its accompanying nutrition education material. Correct scores on the items on the questionnaire will be added up for a total score, with differences between the start of the study and the end of the study compared and also a comparison between the intervention and control groups.

次要结局

  • Score of Nutrition Behaviour as Assessed by the NutriSTEP Questionnaire(12 weeks)
  • Score of Attitudes and Self-Efficacy as Determined by the NutriSTEP Attitudes and Self-Efficacy Questionnaire(12 weeks)
  • Score of Intentions to Change Behaviour as Determined by the NutriSTEP Intentions Questionnaire(12 weeks)

研究者

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

Janis Randall Simpson

College Professor Emerita

University of Guelph

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