Clinical trial NCT04219800: Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)
Official title: Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Norrbottens County Council
name: Vastra Gotaland Region
name: Region Östergötland
name: Region Stockholm
name: Region Örebro County
name: Region Västerbotten
name: Region Jämtland Härjedalen
First posted: 2020-01-07
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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)


Eligibility criteria: 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

Primary outcomes:
measure: Sitting time
timeFrame: 12 months
Secondary outcomes:
measure: Steps
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Cardiometabolic composite score (CCMR)
timeFrame: 12 months
measure: Sick leave
timeFrame: 12 months
measure: Medications
timeFrame: 12 months
measure: Musculoskeletal problems
timeFrame: 12 months
Other outcomes:
measure: General self-efficacy
timeFrame: 12 months
Locations:
city: Luleå
country: Sweden
facility: Björkskatans Hälsocentral
state: Norrbotten
city: Hallsberg
country: Sweden
facility: Hallsbergs hälsocentral
city: Linköping
country: Sweden
facility: Kärna Vårdcentral
city: Stockholm
country: Sweden
facility: Torsviks Vårdcentral
city: Umeå
country: Sweden
facility: Clinical Research Centre
city: Östersund
country: Sweden
facility: Clinical Research Centre
Study officials:
affiliation: Umeå University
name: Patrik Wennberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.