Study period | |||||||||
Enrolment | Allocation | Study visits/sessions | Delivery | ||||||
Time point | Baseline=week 0 (<20 weeks’ gestation) | Week 0 | Week 2 | Week 4 | ~Week 8 | Follow-up visit = ~Week 12 (24–28 weeks’ gestation) | ~Week 16 | ~Week 20 | Week 24 |
Enrolment: | |||||||||
Eligibility screening | X | ||||||||
Informed consent | X | ||||||||
Randomisation | X | ||||||||
Trial arms: | |||||||||
RECORD programme | X | X | X | X | |||||
+ telephone support | X | X | X | X | X | X | |||
Usual care | X | X | X | X | |||||
Assessments: | |||||||||
Demographics | X | ||||||||
Weight | X | X | |||||||
Height | X | ||||||||
Blood pressure | X | X | |||||||
OGTT | X | X | |||||||
EQ-5D | X | X | |||||||
Self-completed 24-hour dietary recall | X | X | |||||||
Fasting plasma insulin | X | X | |||||||
HbA1c | X | X | |||||||
Self-monitoring of fasting capillary glucose | Twice a week for the study duration | ||||||||
Self-monitoring of fasting capillary ketones | Twice a week for the study duration | ||||||||
Self-weighing (intervention group) | Once a week for the study duration | ||||||||
SAEs | |||||||||
Maternal and neonatal outcomes | X |
EQ-5D, EuroQol-5 Dimensions questionnaire; HbA1c, glycated haemoglobin; OGTT, oral glucose tolerance test; SAEs, serious adverse events.