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临床试验/NCT02393872
NCT02393872Unknown不适用

Developing and Implementing a Community-based Intervention to Create a More Supportive Social and Physical Environment for Lifestyle Changes to Prevent Diabetes in Vulnerable Families Across Europe.

Harokopio University1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
9,000
试验地点
1
主要终点
Body mass index (BMI)

研究概览

简要总结

The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.

详细描述

The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.

The Feel4Diabetes-intervention will be developed according to the results of systematic literature reviews, narrative reviews and surveys regarding existing research programs, legislation and policies as well as infrastructures, facilities and human resources, which will be conducted during the first phase of the project. It will be implemented in six Eurepean countries, namely Belgium, Bulgaria, Finland, Greece, Hungary and Spain. The process, impact, outcome, cost-effectiveness and scalability of the Feel4Diabetes-intervention will be evaluated and the results of the study will be disseminated via various communication channels.

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 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For children and their parents: low socioeconomic areas and/or vulnerable subgroups of population
  • •For children: first two grades of compulsory education.

排除标准

  • •Age range not within the inclusion criteria.

研究组 & 干预措施

High-risk families component

Experimental

School-based intervention and counselling sessions.

干预措施: Feel4Diabetes-intervention (Behavioral)

All-families component

Experimental

School-based intervention.

干预措施: Feel4Diabetes-intervention (Behavioral)

Control

No Intervention

Control group.

结局指标

主要结局

Body mass index (BMI)

时间窗: 1 year

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

Associate Professor

Harokopio University

研究点 (1)

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