Skip to main content
OpenTrials
Completed

NCT Number: NCT04219800

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Björkskatans Hälsocentral, Luleå, Norrbotten County, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Patient-centered counselling and written material

Behavioral

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

mHealth

Behavioral
  • Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps.
  • SMS text messages; reminds of activity breaks.
  • Mobile video instruction for standing pause gymnastics.

Primary outcomes

  1. Sitting time

    Time frame: 12 months

    Assessed by activPAL3 thigh-worn accelerometer

Secondary outcomes

  1. Steps

    Time frame: 12 months

    Assessed by activPAL3 thigh-worn accelerometer

  2. Fatigue

    Time frame: 12 months

    MFI-20 questionnaire

  3. Health-related quality of life

    Time frame: 12 months

    RAND-36 questionnaire

  4. Cardiometabolic composite score (CCMR)

    Time frame: 12 months

    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

  5. Sick leave

    Time frame: 12 months

    Assessed by diary

  6. Medications

    Time frame: 12 months

    Total use of medications

  7. Musculoskeletal problems

    Time frame: 12 months

    NRS questionnaire

Other outcomes

  1. General self-efficacy

    Time frame: 12 months

    GSE-10 questionnaire

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Norrbottens County Council
  • Region Jämtland Härjedalen
  • Region Stockholm
  • Region Västerbotten
  • Region Örebro County
  • Region Östergötland
  • Vastra Gotaland Region

Registry information

Acronym: ROSEBUD

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 7, 2020
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.