Table 1.
Schedule for enrolment, interventions and assessments
| Time point | Measurement | Evaluator | Enrolment | Allocation | T0 | T1 | T2 |
| Screening | X | ||||||
| Informed consent | X | ||||||
| Allocation | X | ||||||
| Intervention group | |||||||
| TAU (medical diabetes treatment) | X | X | X | X | |||
| dbcoach (telephone coaching, app) | X | X | X | X | |||
| Control group | |||||||
| TAU (medical diabetes treatment) | X | X | X | X | |||
| dbcoach-app, written recommendation | X | X | X | X | |||
| Inclusion criteria | |||||||
| Age >18 years old | Screening | Study team | X | ||||
| HbA1c>7.5 % | Screening | Physician | X | ||||
| T2D according to ADA | Screening | Physician | X | ||||
| Sufficient knowledge of German language | Screening | Physician | X | ||||
| Access to ongoing diabetes care | Screening | Physician | X | ||||
| Internet access | Screening | Study team | X | ||||
| Physically inactive | Screening | Study team | X | ||||
| Primary outcomes | |||||||
| HbA1c | Medical report | Physician | X | X | X | ||
| Objectively assessed physical activity | ActiGraph wGT3X-BT | Objective | X | X | X | ||
| Secondary outcomes | |||||||
| Self-reported physical activity | SIMPAQ questionnaire | Self-rating | X | X | X | ||
| Cognitive mediators of behaviour change | Sport related: | Self-rating | |||||
|
X | X | X | ||||
|
X | X | X | ||||
|
X | X | X | ||||
|
X | X | X | ||||
|
X | X | X | ||||
|
X | X | X | ||||
| Nutrition | Nutrition diary, Healthy Eating Index | Self-rating | X | X | X | ||
| Nutrition behaviour | SEV questionnaire | Self-rating | X | X | X | ||
| Quality of life | SF-8 questionnaire | Self-rating | X | X | X | ||
| Neuropathy | FACT questionnaire | Self-rating | X | X | X | ||
| Medication | Medical report | Physician | X | X | X | ||
| Food supplements | Medical report | Physician | X | X | X | ||
| Anthropometry | Medical report | Physician | X | X | X | ||
| Blood values | Medical report | Physician | X | X | X | ||
| Comorbidities | Medical report | Physician | X | X | X | ||
| Cost-effectiveness | Tarmed V.1.09 | Study team | X | X | X | ||
| Demographic variables | Demographic questionnaire | Self-rating | X | ||||
ADA, American Diabetes Association; FACT, Functional Assessment of Cancer Therapy; HbA1c, glycated haemoglobin; SEV, Eating Behaviour Scale; SF-8, Short Form-8 Health Survey; SIMPAQ, Simple Physical Activity Questionnaire; TAU, treatment as usual; T2D, type 2 diabetes.