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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.
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BMC Pregnancy and Childbirth

ISSN: 1471-2393

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