Pregnant women with a pre-pregnancy body mass index (BMI) ≥ 29 kg/m2 are eligible for inclusion
[17 (link)]. Where pre-pregnancy weight is not known the most earliest antenatal weight will be used. Further inclusion criteria are: before 19+6days of gestation, singleton pregnancy and aged ≥ 18 years.
Women will be excluded from the study if they: are diagnosed with GDM on oral glucose tolerance testing, before randomization, using IADPSG criteria defined as fasting venous plasma glucose ≥ 5.1 mmol/l and/or 1 hour glucose ≥10 mmol/l and/or 2 hour glucose ≥ 8.5 mmol/l at baseline measurement
[18 (link)]; have pre-existing diabetes; are not able to walk at least 100 meter safely; require complex diets; have chronic medical conditions (e.g. valvular heart disease); have significant psychiatric disease; are unable to speak major language of the country of recruitment fluently or are unable to converse with the lifestyle coach in another language for which translated materials exist. For the vitamin D arm, two additional exclusion criteria apply: have current or past abnormal calcium metabolism, e.g. hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria; have hypercalciuria (>0.6 mmol/mmol creatinine in spot morning urine) or hypercalcaemia (>10.6 mg/dl | 2.65 mmol/l) detected at baseline measurement.
Women who have developed GDM at baseline are informed that they can not participate any further in DALI and are recommended to contact their health care provider regarding their GDM. These women are asked to consent to have the information regarding their pregnancy outcomes collected. As the IADPSG criteria are not used to diagnose GDM at all sites, each site has a protocol on how to link women with appropriate services in their locality.
[17 (link)]. Where pre-pregnancy weight is not known the most earliest antenatal weight will be used. Further inclusion criteria are: before 19+6days of gestation, singleton pregnancy and aged ≥ 18 years.
Women will be excluded from the study if they: are diagnosed with GDM on oral glucose tolerance testing, before randomization, using IADPSG criteria defined as fasting venous plasma glucose ≥ 5.1 mmol/l and/or 1 hour glucose ≥10 mmol/l and/or 2 hour glucose ≥ 8.5 mmol/l at baseline measurement
[18 (link)]; have pre-existing diabetes; are not able to walk at least 100 meter safely; require complex diets; have chronic medical conditions (e.g. valvular heart disease); have significant psychiatric disease; are unable to speak major language of the country of recruitment fluently or are unable to converse with the lifestyle coach in another language for which translated materials exist. For the vitamin D arm, two additional exclusion criteria apply: have current or past abnormal calcium metabolism, e.g. hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria; have hypercalciuria (>0.6 mmol/mmol creatinine in spot morning urine) or hypercalcaemia (>10.6 mg/dl | 2.65 mmol/l) detected at baseline measurement.
Women who have developed GDM at baseline are informed that they can not participate any further in DALI and are recommended to contact their health care provider regarding their GDM. These women are asked to consent to have the information regarding their pregnancy outcomes collected. As the IADPSG criteria are not used to diagnose GDM at all sites, each site has a protocol on how to link women with appropriate services in their locality.
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