Prevention With the Health and Lifestyle Tool

January 26, 2023 updated by: Region Skane

Prevention and Development of Lifestyle Diseases With the Health and Lifestyle Tool

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

77000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skane
      • Malmö, Skane, Sweden, 20502
        • Recruiting
        • Anders Rosengrentest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usage of tool
Participants get access to the tool and use it regularly
Behavioral: Lifestyle tool
Regular use of the digital Lifestyle tool
No Intervention: Controls on usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of type 2 diabetes
Time Frame: 3 years
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
Time Frame: 3 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Anxiety estimated by General Anxiety Disorder 7-item scale
Time Frame: 1 year
Change of Anxiety estimated by General Anxiety Disorder 7-item scale relative to baseline compared between participants regularly using the tool and on usual care. Score is from 0 to 21 with 21 meaning highest anxiety
1 year
Change of Patient Health Questionnaire 9-item scale
Time Frame: 1 year
Change of Patient Health Questionnaire 9-item scale relative to baseline compared between participants regularly using the tool and on usual care. Score is from 0 to 27 with 27 meaning highest sign of depression
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Anders Rosengren, Prof, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Anticipated)

August 15, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Lifestyle1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results will be shared after deidentification.

IPD Sharing Time Frame

Data will be available after publication.

IPD Sharing 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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