Table 1.
Schedule of enrolment, interventions, and assessments
| Enrolment | Start | 3 months | 6 months | 9 months | 12 months | 24 months | 36 months | +12 months | |
|---|---|---|---|---|---|---|---|---|---|
| Visit | SE | V0 | V1 | V1–6 | V1–9 | V2 | V3 | V4 | Follow-up |
| Enrolment | |||||||||
| Eligibility screen | X | ||||||||
| Informed consent | X | ||||||||
| Randomisation | X | ||||||||
| Interventions | |||||||||
| Intervention group (I) | X | X | X | X | X | X | X | X | X |
| Control group (C) | X | X | X | X | X | X | |||
| Assessments | |||||||||
| Clinical baseline | C + I | ||||||||
| Clinical follow up | C + I | C + I | C + I | C + I | |||||
| Spiroergometry | C + I | C + I | C + I | ||||||
| Accelerometry | C + I | C + I | C + I | C + I | C + I | ||||
| Questionnaire “training” (IPAQ-L) | C + I | C + I | C + I | C + I | C + I | C + I | C + I | ||
| Questionnaire “nutrition” (MEDAS, EPIC-FFQ) | C + I | C + I | I | I | C + I | C + I | C + I | ||
| Lab | C + I | C + I | C + I | C + I | C + I | ||||
| Clinical examination | C + I | C + I | C + I | C + I | C + I | ||||
| Anthropometry | C + I | C + I | C + I | C + I | C + I | ||||
| Psychological questionnaires | C + I | C + I | C + I | C + I | C + I | ||||