Clinical trial NCT05006508: Prevention With the Health and Lifestyle Tool
Official title: Prevention and Development of Lifestyle Diseases With the Health and Lifestyle Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 77000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants get access to the tool or get assigned to a control group without access.
Primary purpose: PREVENTION

Brief summary: 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: 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:

1. 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)
2. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of type 2 diabetes
timeFrame: 3 years
measure: Change of long-term blood glucose concentration measured as glycated hemoglobin at end of follow-up
timeFrame: 3 years
Secondary outcomes:
measure: Change of Anxiety estimated by General Anxiety Disorder 7-item scale
timeFrame: 1 year
measure: Change of Patient Health Questionnaire 9-item scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Anders Rosengrentest
state: Skane
Study officials:
affiliation: Göteborg University
name: Anders Rosengren, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dwibedi C, Abrahamsson B, Rosengren AH. Effect of Digital Lifestyle Management on Metabolic Control and Quality of Life in Patients with Well-Controlled Type 2 Diabetes. Diabetes Ther. 2022 Mar;13(3):423-439. doi: 10.1007/s13300-022-01214-2. Epub 2022 Feb 12.