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

Umeå University

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: mHealth; Behavioral: Patient-centered counselling and written material

Study type: Interventional

Funder types: Other

Identifiers

NCT04219800

2019-05383

Details and patient eligibility

About

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)

Enrollment: 142 estimated patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

mHealth

Experimental group

Description:

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.

Treatment:

Behavioral: mHealth

Behavioral: Patient-centered counselling and written material

Control

Other group

Description:

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

Treatment:

Behavioral: Patient-centered counselling and written material