Diabetes Mellitus, Type 2
Conditions
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)
Interventions
BEHAVIORALPatient-centered counselling and written material
Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
BEHAVIORALmHealth
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.
Sponsors
Umeå University
Norrbottens County Council
Vastra Gotaland Region
Region Östergötland
Region Stockholm
Region Örebro County
Region Västerbotten
Region Jämtland Härjedalen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sitting time | 12 months | Assessed by activPAL3 thigh-worn accelerometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps | 12 months | Assessed by activPAL3 thigh-worn accelerometer |
| Fatigue | 12 months | MFI-20 questionnaire |
| Health-related quality of life | 12 months | RAND-36 questionnaire |
| Cardiometabolic composite score (CCMR) | 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 |
| Sick leave | 12 months | Assessed by diary |
| Medications | 12 months | Total use of medications |
| Musculoskeletal problems | 12 months | NRS questionnaire |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORPatrik Wennberg
Umeå University
Outcome results
None listed