LIVING - Physical Activity in a Self-management Program Among Persons With Type 2 Diabetes
1 other identifier
interventional
288
1 country
1
Brief Summary
The goal of this pragmatic clinical trial is to evaluate two municipality-based interventions, Lev Livet (one without physical activity and one with) against no intervention in people with type 2 diabetes. The main questions it aims to answer are: • What is the additive effect of HiiT on accelerometer-measured physical activity? • Which factors that facilitate or limit the implementation of Lev Livet? • What are the health-economic implications of the intervention? Participants will participate in a disease management program with and without physical activity added. Researchers will compare with no intervention to see if Lev Livet improves diabetes self-management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2023
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
October 25, 2023
October 1, 2023
2.8 years
October 13, 2023
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The between group differences for change in Perceived competence in Diabetes (PCS-5)
PCS-5 is a five 5-item scale with seven response categories from not at all true to very, true, assessing the degree to which the individual feel they can manage their diabetes. Range 7-35 with higher scores indicating higher competences in managing own diabetes.
From baseline to endpoint (month 3) and follow-up (month 5, 8 and 12)
Secondary Outcomes (1)
The between group differences for change in physical activity
From baseline to endpoint (month 3) and follow-up month 5
Study Arms (4)
Lev Livet
EXPERIMENTALThe participants will receive the 9 weeks of Lev Livet intervention
Lev Livet control
NO INTERVENTIONThe participants will attend 5 months of waiting list
Lev Livet + HiiT
EXPERIMENTALThe participants will receive the 9 weeks of Lev Livet intervention AND 9 weeks of HiiT training
Lev Livet + HiiT control
NO INTERVENTIONThe participants will attend 5 months of waiting list
Interventions
The program consists of a total of 9 sessions with a duration of two and a half to three hours for each session. In the first four sessions coping skills are taught across different chronic diseases. In this part of the program citizens suffering from different chronic diseases can participate. Citizens living with T2D then move on to four diabetes-specific sessions, followed by a ninth follow up session. The sessions are held consecutively over eight weeks. The ninth session is held three weeks after the eighth session. The 8 weeks supervised HIIT-protocol will be comprised of blocks of 5 x 1 min high-intensity intervals interrupted by 1 min active recovery. The HIIT intervention will progress continuously, from two weekly training sessions with two training blocks (22 minutes of training) in the first two weeks, to two weekly training sessions with four training blocks in the last four weeks of the intervention.
Eligibility Criteria
You may qualify if:
- Diagnosed with T2D
- Age \>=18 years
- able to speak and understand Danish
- individuals assessed fit by a health care professional to attend a diabetes self-management program
You may not qualify if:
- Contraindication to increasing level of physical activity assessed by the participant' general practitioner (e.g. unstable angina, uncontrolled arrhythmias or severe aortic stenosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Region Zealandcollaborator
Study Sites (1)
Steno Diabetes Center Aarhus
Aarhus N, 8200, Denmark
Related Publications (1)
Jensen JM, Sorensen KV, Stovring H, Andersen A. LIVING - protocol for a pragmatic randomized controlled trial investigating the effect of three different levels of diabetes self-management programs. Contemp Clin Trials. 2025 Jun;153:107891. doi: 10.1016/j.cct.2025.107891. Epub 2025 Mar 29.
PMID: 40164303DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anette Andersen
Aarhus University Hospital, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 19, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share