Assessment of the Health and Lifestyle Tool

NCT04624321 | Active Not Recruiting

• 1 other identifier: Health1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change of long-term blood glucose concentration measured as glycated hemoglobin at 3 months

  Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 3 months relative to baseline compared between participants with access to the tool and on usual care.

  3 months

• Change of long-term blood glucose concentration measured as glycated hemoglobin at one year

  Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at one year relative to baseline between participants who use the tool as recommended and matched controls on usual care

  One year of the open-label observation period

Secondary Outcomes (6)

• Change of long-term blood glucose concentration measured as glycated hemoglobin at three years

  Three years of the open-label observation period

• Body weight

  3 months, 1 year and 3 years

• Insulin resistance

  3 months, 1 year and 3 years

• Fasting blood glucose concentration

  3 months, 1 year and 3 years

• Physical activity in calories per day

  3 years

Other Outcomes (1)

• Change of long-term blood glucose concentration measured as glycated hemoglobin in participants with and without Mild Obesity-related Diabetes, respectively.

  1 year and 3 years

Study Arms (2)

Access to tool

EXPERIMENTAL

Access to the digital tool. They use the tool at their own and do the different themes that are available. They are recommended to use it at least every other week.

Behavioral: Health and lifestyle tool

Usual care

PLACEBO COMPARATOR

They are followed by their ordinary healthcare provider.

Other: Usual care

Interventions

Health and lifestyle tool BEHAVIORAL

Health and lifestyle tool used online

Access to tool

Usual care OTHER

Usual care at ordinary healthcare provider

Usual care

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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
• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Clinical Research Center

Malmo, Skåne County, 20502, Sweden

Location

Related Publications (2)

• Salunkhe VA, Sinha N, Ahlqvist E, Prasad RB, Johansson S, Abrahamsson B, Rosengren AH. Digital lifestyle treatment improves long-term metabolic control in type 2 diabetes with different effects in pathophysiological and genetic subgroups. NPJ Digit Med. 2023 Oct 26;6(1):199. doi: 10.1038/s41746-023-00946-0.

  PMID: 37884680 DERIVED

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Health

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Anders Rosengren

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study has an initial 3-month randomization phase with two parallel arms, one randomized to access the lifestyle tool and one randomized to a wait list on usual care. After that 3-month period, all participants will get access to the tool, independent of previous randomization assignment, and are followed over three years in an open-label observation period where changes to HbA1c and secondary variables are compared against matched controls on usual care.

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 10, 2020
• Study Start: January 1, 2021
• 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)