Primary Prevention With the Lifestyle Tool

NCT05309850 | Recruiting

• 1 other identifier: Lifestyle2
• Study Type: interventional
• Target: 90,000
• 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 and cardiovascular disease in those using the tool regularly and those in the control group.

Conditions

Cardiovascular Diseases; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Incidence of major adverse cardiovascular event

  Incidence of major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure compared between participants regularly using the tool and on usual care.

  3 years

• 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 yars

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. Development of cardiovascular disease or type 2 diabetes is followed 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)

Skane University Hospital

Malmo, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anders Rosengren

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitta Abrahamsson

CONTACT

0705316704; birgitta.x.abrahamsson@skane.se

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: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 5, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 16, 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)