Table 1.
Visit | V0 | V1 | V2 | V3 | V4 |
Time, weeks from start of intervention | −7* | −1 | 6 | 12 | 26 |
Participant information | |||||
Informed consent | X | ||||
Medical history (individual and family) | X | ||||
Inclusion and exclusion criteria | X | ||||
Pregnancy test (fertile women only) | X | X | X | X | |
Efficacy outcomes | |||||
HbA1c | X | X | X | X | X |
Body weight | X | X | X | X | X |
Waist and hip circumference | X | X | X | X | |
Body composition (DXA scanning) | X | X | X | X | |
Blood pressure and resting heart rate | X | X | X | X | X |
Stool sample | X | X | |||
Fasting blood samples | X | X | X | X | |
Postprandial blood samples | X | X | |||
Indirect calorimetry | X | X | |||
Heart rate variability (Vagus) | X | X | |||
Mixed meal test with SmartPill | X | X | |||
Event registration related to SmartPill | X | X | |||
Physical activity and sleep measurement | X | X | X | ||
Food records | X | X | X | ||
Continuous glucose monitoring | X | X | X | ||
Fasting food reward and biometric measurements | X | X | X | X | |
Postprandial food reward and biometric measurements | X | X | |||
Questionnaires | |||||
Sociodemographic characteristics | X | ||||
Health and well-being | X | X | X | X | |
Physical activity | X | X | X | X | |
Fasting appetite sensations | X | X | X | X | |
Postprandial appetite sensations | X | X | |||
Gastrointestinal symptoms | X | X | X | X | |
Autonomic symptoms | X | ||||
Pain | X | ||||
Sleep quality and sleepiness | X | X | X | X | |
Chronotype | X | X | X | X | |
Night eating | X | X | X | X | |
Eating behaviour and control over eating | X | X | X | X | |
Interviews | |||||
Interview† | X | ||||
Interview (participants in the TRE group)‡ | X | X |
*Max 6 weeks before baseline testing (V1).
†Interview regarding motivation for participation.
‡Interview regarding feasibility and maintenance.
DXA, dual-energy X-ray absorptiometry; HbA1c, glycated haemoglobin; TRE, time-restricted eating; V0, screening; V1, baseline testing; V2, mid-intervention testing (after 6 weeks); V3, post-intervention testing (after 3 months); V4, follow-up testing (after 6 months).