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临床试验/NCT03819673
NCT03819673已完成不适用

A Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity

Harokopio University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年5月1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
65
试验地点
2
主要终点
Body Mass Index (BMI)

研究概览

简要总结

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

详细描述

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

The effectiveness of the decision support tool was assessed through a pilot randomized controlled intervention trial (RCT). The RCT was initiated on May 2018 and was conducted in the Endocrinology Department of the "P. A. Kyriakou" Children's Hospital and in the Division of Endocrinology, Metabolism, and Diabetes of the "Aghia Sophia" Children's Hospital in Athens, Greece.

Sixty-five overweight or obese children that were eligible to participate in the RCT, were randomly and equally allocated to two study groups. Those children that were randomly allocated to the intervention group (IG), were examined by health professionals (i.e. paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of the decision support tool. The latter assisted the medical professionals to assess children's weight status, to set appropriate weight management goals and provide personalised meal plans and/or recommendations to children and their families. On the contrary, those children that were randomly allocated to the control group (CG) received the usual care advice that is routinely provided to children in the two hospitals and includes child visits and follow-up appointments for weight checks with their primary care provider or dietitian.

The effectiveness of the intervention was evaluated through the collection of data at baseline and at a follow-up examination after 3 months.

All data were uploaded to the decision-support tool, which analysed them and extracted a report with the child's assessment, as well as with personalised diet and lifestyle optimization recommendations. More specifically, the decision support tool proposed personalised weekly meal plans adjusted to the estimated energy requirements calculated for each child, as well as personalised diet and lifestyle optimization advice recommendations for the child and/or the entire family. Lastly, the decision support tool suggested a periodic re-evaluation every 3 or 6 months depending on the child's current weight status, the presence of obesity-related comorbidity in children and the presence of obesity in at least one or both parents.

研究设计

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

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-12 years old
  • Overweight status or obesity (i.e. BMI-for-age > 85th percentile)

排除标准

  • Age range not within the inclusion criteria

研究组 & 干预措施

Intervention Group (IG)

Experimental

Care based on the computerised decision-support tool

干预措施: Intervention Group Care (Behavioral)

Control Group (CG)

No Intervention

Usual care advice by primary care provider or dietitian of participating hospital

结局指标

主要结局

Body Mass Index (BMI)

时间窗: 3-6 months

次要结局

未报告次要终点

研究者

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

Yannis Manios

Principal Investigator

Harokopio University

研究点 (2)

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