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. 2020 Aug 26;10(8):e037166. doi: 10.1136/bmjopen-2020-037166

Table 1.

Overview of study visits

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).