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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Patient-centered counselling and written material; Behavioral: mHealth

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Hallsberg, Sweden
    • Hallsbergs hälsocentral
  • Linköping, Sweden
    • Kärna Vårdcentral
  • Stockholm, Sweden
    • Torsviks Vårdcentral
  • Umeå, Sweden
    • Clinical Research Centre
  • Östersund, Sweden
    • Clinical Research Centre
  • Norrbotten County
    • Luleå, Norrbotten County, Sweden
      • Björkskatans Hälsocentral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth; 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.	Behavioral: Patient-centered counselling and written material; Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.; Behavioral: mHealth; 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.
Other: Control; Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.	Behavioral: Patient-centered counselling and written material; Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting time	Assessed by activPAL3 thigh-worn accelerometer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps	Assessed by activPAL3 thigh-worn accelerometer	12 months
Fatigue	MFI-20 questionnaire	12 months
Health-related quality of life	RAND-36 questionnaire	12 months
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	12 months
Sick leave	Assessed by diary	12 months
Medications	Total use of medications	12 months
Musculoskeletal problems	NRS questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General self-efficacy	GSE-10 questionnaire	12 months

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Vastra Gotaland Region; Region Östergötland; Region Stockholm; Region Örebro County; Region Västerbotten; Norrbottens County Council; Region Jämtland Härjedalen
• Investigators: Principal Investigator: Patrik Wennberg, Umeå University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: 2019-05383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No