Prevention With the Health and Lifestyle Tool

NCT05006508 | Active Not Recruiting

• 1 other identifier: Lifestyle1
• Study Type: interventional
• Target: 77,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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

• Prescription of anxiolytic medication

  Number of participants on prescription of anxiolytic medication between participants regularly using the tool and on usual care.

  3 years

• Prescription of antidepessive medication

  Number of participants on prescription of antidepressive medication between participants regularly using the tool and on usual care.

  3 years

Secondary Outcomes (2)

• Change of Anxiety estimated by General Anxiety Disorder 7-item scale

  1 year

• Change of Patient Health Questionnaire 9-item scale

  1 year

Study Arms (2)

Usage of tool

EXPERIMENTAL

Participants get access to the tool and use it regularly

Behavioral: Lifestyle tool

Controls on usual care

NO INTERVENTION

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.

Interventions

Lifestyle tool BEHAVIORAL

Regular use of the digital Lifestyle tool

Usage of tool

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• Age above 35 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Anders Rosengrentest

Malmo, Skåne County, 20502, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35150403 DERIVED

Study Officials

• Anders Rosengren, Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants get access to the tool or get assigned to a control group without access.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: August 16, 2021
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication.
• Access Criteria: To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to internetverktyg@gu.se

Locations

SE (1)