Measurements | Method or sample used | Screening -recruitment period | RCT | |||||
---|---|---|---|---|---|---|---|---|
Baseline (T0) | 6 Months | 1 year (T1) | 2 years (T2) | |||||
SC | HV | SC | HV | |||||
I. Laboratory assessments | Â | Â | Â | Â | Â | Â | Â | Â |
1.Fasting plasma glucose, HbA1c, insulin | Fasting venous blood sample | x | x | Â | x | d | x | d |
2.2-h Postload glucose | 2-h postload glucose | b | x | Â | x | Â | x | Â |
3.Triglycerides, HDL, LDL, cholesterol, creatinine, hs-CRP | Fasting venous blood sample | Â | x | Â | x | Â | x | Â |
4.Albumin and creatinine (urine) | Fasting urine sample | x | x | Â | x | x | x | x |
5.Blood sample storage (serum, EDTA) | Fasting venous blood sample | b | c | Â | Â | Â | x | Â |
II.Anthropometry | Â | Â | Â | Â | Â | Â | Â | Â |
6.Weight, height, blood pressure (Omron M5-1) | SOP: twice, blood pressure measured 5 times | x | x | Â | x | x | x | x |
7. Waist and hip circumferences, fat percentage (Omron 500) | SOP: twice | b | x | Â | x | Â | x | Â |
III. Behavior | Â | Â | Â | Â | Â | Â | Â | Â |
Questionnaire (interview) | Â | x | Â | x | x | x | x | |
9.Diet (based on guideline for healthful diet) | Questionnaire (interview) | x | x | Â | x | x | x | x |
10.Smoking [24] | Questionnaire (interview) | x | x | Â | x | x | x | x |
11.Alcohol [25] | Questionnaire (interview) | x | x | Â | x | x | x | x |
IV. Other measurements a | Â | Â | Â | Â | Â | Â | Â | Â |
12.Ethnicity, household information | Questionnaire | x | Â | Â | Â | Â | Â | Â |
13.Education, income, insurance, religion [26] | Questionnaire (interview) | education | x | Â | x | x | x | x |
14.Physical health (cardiovascular risk profile; [27]) | Questionnaire (interview) | f | g | Â | g | g | g | g |
SOP | Â | x | Â | x | Â | x | Â | |
Questionnaire (interview) | Â | x | Â | x | x | x | x | |
17.Distress (part of 4DSQ; [32]) | Questionnaire (interview) | Â | x | Â | x | x | x | x |
18.Risk perception ([33] and our own questionnaire) | Questionnaire (interview) | Â | x | x | x | x | x | x |
19.Attitude, knowledge, social support, self-efficacy, and stages of change in PA and diet | Questionnaire (interview) | Â | x | Â | x | x | x | x |
20.Perception of one’s own body | Questionnaire (interview) |  | x |  | x | x | x | x |
V. Process | Â | Â | Â | Â | Â | Â | Â | Â |
21.Dose received (participation in intervention components, frequency, leaflet, satisfaction) | Questionnaire (interview) | Â | Â | x | Â | Â | Â | Â |
VI. Costs | Â | Â | Â | Â | Â | Â | Â | Â |
1.Use of health care | Questionnaire (interview) | Â | x | Â | x | x | x | x |
2.Costs of screening and lifestyle intervention | Questionnaire (interview) | h | x | Â | x | x | x | x |