Study phase | Screening phase | Follow-up phase | |||||||
---|---|---|---|---|---|---|---|---|---|
Visit | Screening | Â | Â | Â | Â | Â | Â | Â | End of study |
Scheduled timeline in months (M) (from the date of baseline assessment) | Within -1 M | 0 M | 3 M | 6 M | 12 M | 18 M | 24 M | 30 M | 36 M |
Participant referral | • |  |  |  |  |  |  |  |  |
Informed consent | • |  |  |  |  |  |  |  |  |
Inclusion/exclusion criteria |  | • |  |  |  |  |  |  |  |
Medical history |  | • |  |  |  |  |  |  |  |
Demographics |  | • |  |  |  |  |  |  |  |
Randomization |  | • |  |  |  |  |  |  |  |
Physical examinations | |||||||||
Weight, height, waist circumference |  | • | • | • | • | • | • | • | • |
Heart rate |  | • | • | • | • | • | • | • | • |
Systolic and diastolic blood pressure |  | • | • | • | • | • | • | • | • |
Laboratory assessments | |||||||||
Cholesterol level: Total cholesterol, HDL-c, LDL-c, triglycerides |  | • |  | • | • | • | • | • | • |
HbA1c |  | • |  | • | • | • | • | • | • |
Fasting plasma glucose |  | • |  | • | • | • | • | • | • |
2-hour plasma glucose |  | • |  |  | • |  | • |  | • |
75 g OGTT |  | •a |  |  | • |  | • |  | • |
Retinal photography | |||||||||
Vision media opacity, diabetic retinopathy, diabetic maculopathy |  | • |  |  | • |  | • |  | • |
Questionnaires | |||||||||
Food Frequency Questionnaire |  | • |  | • | • |  |  |  |  |
Health status (EQ-5D-5L) |  | • |  | • | • | • | • | • | • |
Physical activity (IPAQ) |  | • |  | • | • | • | • | • | • |
Work impairment (WPAI:GH) |  | • |  | • | • | • | • | • | • |