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. 2022 Jun 1;12(6):e057948. doi: 10.1136/bmjopen-2021-057948

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
  • Goal intention

X X X
  • Self-concordance

X X X
  • Consequence experience

X X X
  • Barrier management

X X X
  • Action planning

X X X
  • Self-efficacy

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.