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LIVING - Physical Activity in a Self-management Program Among Persons With Type 2 Diabetes

NCT06091501 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2023-10-25

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Randomized Controlled Trial

Interventions

BEHAVIORAL

Lev Livet

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Region Zealand

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anette Andersen · Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091501 on ClinicalTrials.gov