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ACTIVE NOT RECRUITING
NCT04624321
NA

Assessment of the Health and Lifestyle Tool

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

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.

Official title: Study to Evaluate the Digital Health and Lifestyle Tool Developed at the University of Gothenburg

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-01-01

Completion Date

2026-12-31

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

Health and lifestyle tool

Health and lifestyle tool used online

OTHER

Usual care

Usual care at ordinary healthcare provider

Locations (1)

Clinical Research Center

Malmo, Skåne County, Sweden