Prevention With the Health and Lifestyle Tool

Study Overview
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Brief Summary
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In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes over three years in those using the tool regularly and those in the control group.

Detailed Description
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Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine HbA1c. Modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of lifestyle as medicine. Digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness. The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes. The investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. The participants will complete the Findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of high-risk individuals. The study is an investigator-initiated single-center study conducted over three years. The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time. There is no interaction between individual participants. There will be two primary endpoints: Incidence of type 2 diabetes as measured in non-diabetic participants with increased risk for type 2 diabetes (controls vs. those using the tool regularly) Change of HbA1c, reflecting long-term blood glucose control, from baseline to end of follow-up in participants who have type 2 diabetes (controls vs. those using the tool regularly).

Official Title
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Prevention and Development of Lifestyle Diseases With the Health and Lifestyle Tool

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent Age above 35 years Exclusion Criteria: type 1 diabetes, MODY or secondary diabetes 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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants get access to the tool or get assigned to a control group without access.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usage of tool<br>Participants get access to the tool and use it regularly | Behavioral: Lifestyle tool<br>* Regular use of the digital Lifestyle tool<br>|
| No Intervention: Controls on usual care<br>Participants who get randomized to control cannot access the tool and get no further follow-up. Their development of type 2 diabetes or development of HbA1c is tracked via clinical registries. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of type 2 diabetes | Incidence of type 2 diabetes 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 | 
| Change of long-term blood glucose concentration measured as glycated hemoglobin at end of follow-up | Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at end of follow-up relative to baseline compared between participants regularly using the tool and on usual care. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Anxiety estimated by General Anxiety Disorder 7-item scale | Change of Anxiety estimated by General Anxiety Disorder 7-item scale relative to baseline compared between participants regularly using the tool and on usual care. Score is from 0 to 21 with 21 meaning highest anxiety | 1 year | 
| Change of Patient Health Questionnaire 9-item scale | Change of Patient Health Questionnaire 9-item scale relative to baseline compared between participants regularly using the tool and on usual care. Score is from 0 to 27 with 27 meaning highest sign of depression | 1 year |