Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Patients will be randomly assigned to the intervention group or the control group by an independent person, stratified by age, sex, and BMI. Randomization will be conducted as permuted block randomiza
Sponsors
University of Basel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/06/2021: Type 2 diabetes patients will be included in the study if they: 1. Have an HbA1c value above 7.5 2. Have type 2 diabetes as defined by the American Diabetes Association 3. Are able to understand German at a sufficient level to comprehend instructions and information 4. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist 5. Have an Internet connection 6. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week Previous inclusion criteria: Type 2 diabetes patients will be included in the study if they: 1. Are between 18-65 years old 2. Have an HbA1c value above 7.5 3. Have type 2 diabetes as defined by the American Diabetes Association 4. Are able to understand German at a sufficient level to comprehend instructions and information 5. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist 6. Have an Internet connection 7. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week
Exclusion criteria
Exclusion criteria: Patients with type 2 diabetes must be excluded from the study if: 1. They have chronic or acute contraindications to physical activity or cannot be physically active for other medical reasons 2. They suffer from psychiatric or addiction disorders 3. They are pregnant 4. Insulin therapy is being used 5. If the HbA1c value cannot be reliably determined due to medical conditions (in the case of hemoglobinopathy, hemolytic anemia, blood transfusion, HIV, liver or kidney failure requiring dialysis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2): 1. Chronic glycemic control over the last 3 months measured using HbA1c blood marker 2. Duration and intensity of daily physical activity measured using a triaxial accelerometer (ActiGraph wGT3X-BT) around the waist for 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2): 1. Subjective physical activity measured using SIMPAQ questionnaire 2. Nutrition and dietary behavior measured using Nutrition Diary, SEV questionnaire 3. Sport-related cognitive mediators of behavior change measured using questionnaires 4. Quality of life measured using SF-8 questionnaire 5. Neuropathy measured using FACT questionnaire 6. Medication measured using medical report 7. Food supplements measured using medical report 8. Anthropometry (abdominal circumference, hip circumference, height, weight) measured using medical report 9. Blood levels (cholesterol, LDL, non-HDL, Chol/HDL, CRP, IFG) measured using medical report 10. Comorbidities measured using medical report 11. Demographic variables measured using a demographic questionnaire 12. Cost-effectiveness measured using Swiss Medical Association, Tarmed V.1.09 at the end of the study | — |
Countries
Switzerland
Outcome results
None listed