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临床试验/NCT07659535
NCT07659535招募中不适用

Personalized Study With the Lifestyle Tool

Region Skane1 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2026年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
40,000
试验地点
1

研究概览

简要总结

The overall aim of the study is to investigate the incidence of type 2 diabetes in individuals who have access to a digital intervention tool as compared with randomized controls during three years. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.

详细描述

New scalable means to prevent type 2 diabetes is needed. AI-based large language models enable new means to support people in lifestyle changes. It is, however, important that these are coupled with serious health information.

The investigators have previously shown that the digital Livsstilsverktyget ('Lifestyle tool') developed at the University of Gothenburg leads to improved glycemic controls in patients using it regularly. To make the intervention more personal the investigators have coupled it with a large language model (LLM) to promote reflection on the expert-written content of the Lifestyle tool. Thus, participants interact with the LLM to explore a current area of interest. They then get recommendations from the LLM on relevant texts from the Lifestyle tool. These texts are written by experts (physicians, researchers). The participants go through the text and are then stimulate by the LLM to reflect on how to use the content in daily life.

This study will recruit people without type 2 diabetes, aged 35 years or older, from the general population. They will be randomly assigned to the intervention or to a control group without access to the intervention. The primary outcome is the incidence type 2 diabetes during three years. The primary variable, diagnosis of type 2 diabetes, is obtained via national health registers. Thus, no physical visits or blood sampling are required. The participants will complete the Findrisc questionnaire online at baseline to assess the risk for type 2 diabetes and enable effect analysis of individuals with different risk.

The study is an investigator-initiated single-center study conducted over three years. Technical problems are referred to a study coordinator, who also responded to requests to clarify content in a general manner without providing personal advice. Study participants are managed by their ordinary healthcare providers throughout the study.

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
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Age above 35 years
  • Access to Internet and mobile or computer device

排除标准

  • diabetes mellitus
  • conditions or treatments that in the judgement of the Investigator could affect the study evaluation
  • connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
  • living outside of Sweden
  • inability to read and write in Swedish

研究组 & 干预措施

Controls on standard care

No Intervention

Participants who get randomized to control cannot access the tool.

Lifestyle intervention

Experimental

Participants get access to the Lifestyle tool and use it regularly

干预措施: Lifestyle tool (Behavioral)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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