Anders Rosengrentest
Malmö, Skåne County, 20502, Sweden
NCT Number: NCT05006508
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.
This study is active but is not currently recruiting participants.
35 year and older
All sexes
Interventional
Not applicable
Malmö, Skåne County, 20502, Sweden
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 individuals with different risk.
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. 150 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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regular use of the digital Lifestyle tool
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
Number of participants on prescription of anxiolytic medication between participants regularly using the tool and on usual care.
Time frame: 3 years
Number of participants on prescription of antidepressive medication between participants regularly using the tool and on usual care.
Time frame: 1 year
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
Time frame: 1 year
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
Region Skane
Other
Prevention and Development of Lifestyle Diseases With the Health and Lifestyle Tool
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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