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Table 1 Sampling and measurements

From: DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol

  Method or sample used Baseline 24-28wk 35-37wk birth <48 hours postnatal
Physical examinations maternal  
Weight Scale (twice) x x x   
Height Stadiometer (twice) x     
Waist circumference Tape (twice) x     
Neck circumference Tape (once) x x x   
Skin folds (fat percentage) Calliper (twice) x   x   
Blood pressure (systolic, diastolic) and heart rate Twice x x x   
Physical examinations fetus/baby  
Fetal ultrasound a   x x x   
APGAR (1min; 5min)      x  
Neonatal measurements (birth weight, length, head circumference, neonatal body composition (skin fold thickness, circumference of extremities, abdominal circumference) Calliper (twice) and tape      x
Perinatal and obstetric outcome: maternal and neonatal outcome f and complications      x x
Laboratory assessment  
Fasting plasma glucose, HbA1c, insulin b Fasting venous sample x x x   xg
Leptin, vitamin A, vitamin D, carotenoids, 3ß-OH-Butyrate Fasting venous sample x x x   xg
Lipids (triglycerides, free fatty acids, total cholesterol, HDL cholesterol and LDL cholesterol) Fasting venous sample x x x   xg
(30), 60, (90), 120 min plasma glucose and serum insulinb venous sample x xc xc   
Serum calcium and albumin Venous sample xd xd xd   
Urinary calcium/creatinine ratio Morning spot urine xd xd xd   
Cord blood sample Arterial and venous sample     x  
Placenta tissue Tissue sample     x  
Behaviour  
Accelerometer 3 day Actigraph x x x   
PPAQ Questionnaire x x x   
Food diary 3 day Food diary x x x   
12 item food frequency list Questionnaire x x x   
Smoking Questionnaire x   x   
Alcohol Questionnaire x     
Sleeping pattern Questionnaire x x x   
Attitude, knowledge, social support, self-efficacy, risk perception and stages of change in PA and diet Questionnaire x x x   
Barriers and facilitators to change PA and HE Questionnaire    x   
Access to PA venues and healthy food Questionnaire x x x   
Vitamin D  
Travel to warmer climate in winter/spring, sun beds Questionnaire x x x   
Pill count Research nurse   x x x  
Psychosocial       
Health related Quality of life (EQ-5D) Questionnaire x x x x  
WHO Five Well Being index Questionnaire x x x   
Cambridge Worry Scale Questionnaire x x x   
Other  
Household composition, marital status, ethnicity, education, employment, occupation, shift work, parity, age Questionnaire x     
Pre existing condition: family history DM, impaired glucose tolerance, hypertension, polycystic ovarian syndrome Questionnaire x     
Past/current obstetric history Questionnaire x     
Drugs/vitamins/medication Questionnaire x x x x  
Adverse events and safety questions Questionnaire   x x xe  
Questions about the biological father Questionnaire x     
Evaluation  
Dose, reach, fidelity, satisfaction Questionnaire    x   
Costsf, distance, visits Questionnaire x x x   
  1. a Data collected from routine and expert scans that occur during the time points.
  2. b Blood samples will be collected in the fasting state and at [30, 60, 90 and 120 minutes] or [60, and 120 minutes] depending on site following ingestion of the glucose drink (75 g D-glucose in 250 ml water).
  3. c If GDM is diagnosed by IADPSG criteria, subsequent visits only test the fasting measurements.
  4. d obtained locally only for the vitamin D arm.
  5. e at delivery only registration of adverse events.
  6. f data registration for a longer period post natal.
  7. g collection of samples in a non fasting state.
  8. PPAQ pregnancy physical activity questionnaire, PA physical activity, HE healthy eating, WHO world health organisation.