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Diabetes Mellitus, Type 2ROSEBUDNCT04219800

Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)

A study testing Patient-centered counselling and written material and mHealth in people with Diabetes Mellitus, Type 2, run by Umeå University at 6 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 2 diabetes mellitus (T2DM) patients are suboptimal treated due to low uptake of physical activity. Recent research shows promising beneficial health effects from reducing sitting time by regular short bouts of light-intensity physical activity. Read more about this study

Who is it for?
Ages 40 to 64 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Patient-centered counselling and written material and mHealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
6 sitesSweden
Study dates
8 Dec 2020to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Type 2 Diabetes Melltitus
  • 40-64 years
  • HbA1c 48-100 mmol/mol
  • BMI ≥ 25 kg/m2
  • Working at least 75% of full-time in a mainly seated job.

Who cannot join

  • Pregnancy
  • Regular vigorous intensity exercise
  • Severe disease or for other reason unable to follow the study protocol

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Sweden6 sites

  • Hallsbergs hälsocentral

    Hallsberg

  • Kärna Vårdcentral

    Linköping

  • Björkskatans Hälsocentral

    Luleå, Norrbotten County

  • Clinical Research Centre

    Östersund

  • Torsviks Vårdcentral

    Stockholm

  • Clinical Research Centre

    Umeå

Other trials in Sweden

About this study

Type 2 diabetes mellitus (T2DM) patients are suboptimal treated due to low uptake of physical activity. Recent research shows promising beneficial health effects from reducing sitting time by regular short bouts of light-intensity physical activity. These findings open up for a new focus in T2DM treatment but conclusive evidence is missing as studies have been short-term trials, mainly conducted in laboratory environments. Recent research suggest that reduced sitting and increased physical activity can be supported at a low cost by mHealth (mobile health) technology such as activity tracker armbands that warns of prolonged sitting and SMS text messages that reminds of activity breaks.

The overarching purpose of the project is to evaluate the effects of an intervention aimed to reduce occupational sitting in T2DM using mHealth (mobile health). It is hypothesized that the intervention will lead to (1) Activity changes - reduced sitting time and/or increased number of steps (primary outcome measures) and (2) Health effects - lower fatigue, improved health-related quality of life, reduced cardiometabolic risk, less sick leave, less medication, less musculoskeletal problems (secondary outcome measures)

Being tested
Patient-centered counselling and written material, mHealth
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-centered counselling and written materialBehavioural

    Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.

  • mHealthBehavioural

    1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps.
    2. SMS text messages; reminds of activity breaks.
    3. Mobile video instruction for standing pause gymnastics.
Study groups in NCT04219800
Study groupRoleWhat they receive
mHealthExperimental1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps. 2. SMS text messages; reminds of activity breaks. 3. Mobile video instruction for standing pause gymnastics.
Receives: Behavioral: Patient-centered counselling and written material; Behavioral: mHealth
ControlOtherPatient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
Receives: Behavioral: Patient-centered counselling and written material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sitting time

    Assessed by activPAL3 thigh-worn accelerometer

    Measured: 12 months

Secondary outcomes (7)

  1. Steps

    Assessed by activPAL3 thigh-worn accelerometer

    Measured: 12 months

  2. Fatigue

    MFI-20 questionnaire

    Measured: 12 months

  3. Health-related quality of life

    RAND-36 questionnaire

    Measured: 12 months

  4. Cardiometabolic composite score (CCMR)

    Will be determined by summing z-scores ([value-mean]/SD) of waist circumference (cm), mean arterial pressure (mmHg), HbA1c (mmol/mol), the inverse of HDL (mmol/L) and triglycerides (mmol/L), using sex-specific means and SDs

    Measured: 12 months

  5. Sick leave

    Assessed by diary

    Measured: 12 months

  6. Medications

    Total use of medications

    Measured: 12 months

  7. Musculoskeletal problems

    NRS questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start8 Dec 2020
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04219800
Sponsor's protocol ID
2019-05383
Other IDs
2019
Acronym
ROSEBUD
Status last verified
May 2026
First submitted
2 Jan 2020
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Syrjala MB, Bennet L, Dempsey PC, Fharm E, Hellgren M, Jansson S, Nilsson S, Nordendahl M, Rolandsson O, Radholm K, Ugarph-Morawski A, Wandell P, Wennberg P. Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial-the ROSEBUD study. Trials. 2022 Jul 27;23(1):607. doi: 10.1186/s13063-022-06528-x.

    PubMed 35897022

Questions about this trial

What is this clinical trial studying?

A study testing Patient-centered counselling and written material and mHealth in people with Diabetes Mellitus, Type 2, run by Umeå University at 6 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sitting time (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04219800, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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