Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
 | Screening | Baseline and allocation | Post-allocation | Close out | ||||||
Timepoint | T0 | T1 | Allocation | T2 | 12Â weeks | T3 | T4 | |||
Baseline | Intervention start | Intervention end | Final evaluation | |||||||
 | Mesocycle 1 | Mesocycle 2 | Mesocycle 3 | Mesocycle 4 |  |  | ||||
Enrolment: | ||||||||||
 Eligibility screen | X |  |  |  |  |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |  |  |  |  |
 Randomization |  |  | X |  |  |  |  |  |  |  |
Interventions: | ||||||||||
 Intervention group |  |  |  | X | X | X | X | X | X |  |
 Control group |  |  |  |  |  |  |  |  |  |  |
Assessments: | ||||||||||
 Primary outcomes | ||||||||||
  Glycated hemoglobin |  | X |  |  |  |  |  |  |  | X |
 Secondary outcomes |  | X |  |  |  |  |  |  |  |  |
  Capillary blood glucose |  | X |  |  | X | X |  | X |  | X |
  Blood pressure |  | X |  |  |  |  |  |  |  | X |
  Functional capacity |  | X |  |  |  |  |  |  |  | X |
  Quality of Life Questionnaire |  | X |  |  |  |  |  |  |  | X |
  Depressive Symptoms Questionnaire |  | X |  |  |  |  |  |  |  | X |
  Sleep Quality Questionnaire |  | X |  |  |  |  |  |  |  | X |
  Emotional stress related to diabetes questionnaire |  | X |  |  |  |  |  |  |  | X |
  Subjective perception of well-being |  |  |  |  |  |  |  |  |  | X |
Other measures: | ||||||||||
 Anthropometric assessment |  | X |  |  |  |  |  |  |  | X |
 Physical activity levels |  | X |  |  |  |  |  |  |  | X |
 Eating habits |  | X |  |  |  |  |  |  |  | X |