Point of time | Research tandem | Study participant |
---|---|---|
t-1 Week -1 Pre-screening | Data collection form (Study information and consent, participants age, participants sex, inclusion/exclusion criteria, blood sample, laboratory examination, study inclusion, randomization, documentation physical examination) | Â |
t0 Week 0 Study start | Data collection form practice (participants current health situationa) | • Study diaryb • Self-developed Questionnaire (including sociodemographics, current health situation and previous weight management experiences) • Standardized patient questionnaires*** |
Week 1 | Data collection form Visit (IG only) (blood pressure, heart rate, parameters, other examination finds, (serious) adverse events, other aspects of the visit) | Â |
Week 2 | Data collection form Visit (IG only) (blood pressure, heart rate, other examination finds, adverse events, other aspects of the visit) | Â |
Week 5 | Â | Study diaryb |
Week 6 | Data collection form Phone-Visit (IG only) (adverse events, other aspects of the visit) | Â |
Week 11 | Â | Study diaryb |
t1 Week 12 Half-time visit | Data collection form practice (participants current health situationa, laboratory examination) | • Self-developed Questionnaire (including previous weight management experiences) • Standardized patient questionnairesc |
Week 17 | Â | Study diaryb |
Week 23 | Â | Study diaryb |
t2 Week 24 End of intervention | Data collection form practice (participants current health situationa, laboratory examination) | • Self-developed Questionnaire (including sociodemographics and previous weight management experiences) • Standardized patient questionnairesc |
t3 Week 48 Follow-up | Data collection form practice (participants current health situationa) | • Self-developed Questionnaire (including sociodemographics and previous weight management experiences) • Standardized patient questionnairesc |