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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention | Experimental | Participants get access to the Lifestyle tool and use it regularly |
|
| Controls on standard care | No Intervention | Participants who get randomized to control cannot access the tool. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle tool | Behavioral | Regular use of the digital Lifestyle tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of type 2 diabetes | Incidence of type 2 diabetes diagnosed in routine care and reported in national clinical registers, i.e. defined as random plasma glucose >11.1 mmol/L or fasting glucose >7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using the tool and on usual care. | 3 years |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgitta Abrahamsson, MSc | Contact | 0705316704 | birgitta.x.abrahamsson@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Anders Rosengren, MD PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Recruiting | Malmö | Skåne County | 20502 | Sweden |
Individual participant data that underlie the results will be shared after deidentification.
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To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to livsstilsverktyget@gu.se
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants get access to the tool or get assigned to a control group without access.
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| D004700 | Endocrine System Diseases |