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

Study Overview
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Brief Summary
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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)

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Patient-centered counselling and written material
* Behavioral: mHealth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |