NCT04624321Active, not recruiting
Assessment of the Health and Lifestyle Tool
Study to Evaluate the Digital Health and Lifestyle Tool Developed at the University of Gothenburg
Source: ClinicalTrials.gov · Last updated 16 Jul 2025
Brief summary (registry, in English)
The overall aim of the study is to evaluate a digital lifestyle intervention that has been developed in an academic setting at the University of Gothenburg, Sweden. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. The effects of the tool on HbA1c, reflecting long-term blood glucose, will be evaluated in patients with type 2 diabetes. The study will contain two phases. The study consists of a three-month period in which participants are randomly assigned to usual care or access to the intervention tool, followed by an open-label three-year observation period during which participants have access to the tool in addition to ordinary healthcare and are compared with matched controls on usual care.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 30 Oct 2020
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Region Skane
- Diseases
- Type 2 diabetes
- NCT number
- NCT04624321
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jan 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- type 1 diabetes, MODY or secondary diabetes
- conditions or treatments that in the judgement of the Investigator could affect the study evaluation
Other
- inability to understand written Swedish
- 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.
Who the study is looking for
- Patients with type 2 diabetes at or above 35 years of age
- Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication or diagnosed according to the WHO criteria (random plasma glucose \>11.1 mmol/L or fasting glucose \>7.0 mmol/L or HbA1C ≥6.5%).
- written informed consent.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.