Exercise, Type 2 Diabetes Mellitus
Conditions
Brief summary
The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.
Interventions
Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of type 2 diabetes * 18 years of age or older * Ability to communicate in Swedish * Have and be able to use a smartphone
Exclusion criteria
* Not being able to walk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in physical activity level (counts/min from accelerometers) | baseline and month 3, 6 and 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps/day | Baseline and month 3, 6 and 12 | — |
| Total cholesterol (mmol/L) | Baseline and month 3, 6 and 12 | — |
| HDL-cholesterol (mmol/L) | Baseline and month 3, 6 and 12 | — |
| Triglycerides (mmol/L) | Baseline and month 3, 6 and 12 | — |
| Apolipoprotein A1 (g/l) | Baseline and month 3, 6 and 12 | — |
| Apolipoprotein B (g/l) | Baseline and month 3, 6 and 12 | — |
| Body weight (kg) | Baseline and month 3, 6 and 12 | — |
| Body Mass Index (BMI, kg/m2) | Baseline and month 3, 6 and 12 | — |
| Body composition | Baseline and month 3, 6 and 12 | Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %) |
| Waist circumference (cm) | Baseline and month 3, 6 and 12 | — |
| Blood pressure (mmHg) | Baseline and month 3, 6 and 12 | — |
| HbA1c (mmol/mol) | Baseline and month 3, 6 and 12 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in tobacco use habits (smoking and Swedish snuff use) | Baseline and month 3, 6 and 12 | — |
| Change in sleeping habits assessed using a 13 item questionnaire | Baseline and month 3, 6 and 12 | — |
| Change in perceived stress levels using the perceived stress scale | Baseline and month 3, 6 and 12 | — |
| Change in reported self-efficacy for exercise | Baseline and month 3, 6 and 12 | One's confidence in walking is assessed |
| Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire | Baseline and month 3, 6 and 12 | — |
| Change in RAND-36 | Baseline and month 3, 6 and 12 | — |
| Change in neighborhood Environment assessed by questions on safety and walking environment | Baseline and month 3, 6 and 12 | — |
| Social support for exercise assessed using a 6 item questionnaire | Baseline and month 3, 6 and 12 | — |
| Change in dietary habits assessed using a food frequency questionnaire | Baseline and month 3, 6 and 12 | — |
| Change in perceived purpose in life | Baseline and month 3, 6 and 12 | — |
Countries
Sweden
Outcome results
None listed