Table 5.
Procedures and activities during the study period
| Screening visit (V0) |
Pre-baseline visit (V1) | Baseline visit (V2) |
End of trial visit (V3) | |
| Week | −20 to −13 | −9 to −6 | 0 | 10 |
| Visit day | 0 | 1 | 2 | 3 |
| Informed consent | X | |||
| Review of inclusion and exclusion criteria | X | |||
| Medical history and examination | X | |||
| Randomisation | X* | |||
| Registration of medication and adverse events | X | X | X | X |
| Anthropometry | ||||
| Body weight | X | X | X | X |
| Height | X | |||
| Waist circumference | X | X | X | X |
| Body composition (DXA) | X | X | ||
| Biological samples | ||||
| Fasting blood sample | X | X | X | |
| Saliva sample (SNPs) | X | |||
| Urine sample | X | X | X | |
| Faecal sample | X† | X† | ||
| Nutritional assessment | ||||
| Food Frequency Questionnaire | X | X | ||
| 3-day dietary records | X† | X† | ||
| Other measurements | ||||
| Blood pressure/heart rate | X | X | X | |
| Three factor eating questionnaire | X | X | ||
| Perceived Stress Scale | X | X | ||
| Behavioural questionnaire (by ONMI) | X | X | ||
| Quality of Life questionnaires | X | X | ||
| Diet satisfaction questionnaire (DSat-28) | X | X | ||
| Money spent on food questions | X | X | ||
| Accelerometer (sleep and PA) | X‡ | X‡ | ||
*Prior to visit.
†At home activity prior to visit.
‡At home activity following the visit.
DXA, dual-energy X-ray absorptiometry; PA, physical activity.