Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
The SPARK digital platform provides support to the patient (shown as an app) as well as provides the possibility for the health care provider to review and give feedback on blood glucose levels through the care giver interface of the platform.
Maternity health care, Region Östergötland
Linköping, Sweden
RECRUITINGGlucose control
Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring
Time frame: At the end of the intervention in gestational weeks 36-37
HbA1c
Glycosylated hemoglobulin
Time frame: At the end of the intervention in gestational weeks 36-37
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Time frame: At the end of the intervention in gestational weeks 36-37
Physical activity using accelerometry
Time spent on physical activity at different levels (sedentary, light, moderate, vigorous) in minutes per day will be assessed using accelerometry collected during 7 days
Time frame: At the end of the intervention in gestational weeks 36-37
Incidence of pre-eclampsia
Diagnosis of pre-eclampsia
Time frame: Up to delivery
Incidence of Caesarean sections
Delivery by caesarean sections
Time frame: Up to delivery
Incidence of pregnancy induced hypertension
Diagnosis of pregnancy induced hypertension
Time frame: Up to delivery
Metformin/insulin treatment
Introduction of metformin/insulin treatment
Time frame: Up to delivery
Preterm birth
Delivery before 37 completed weeks
Time frame: Up to delivery
Gestational weight gain
Increase in body weight during pregnancy
Time frame: From pre-prepregnancy up to 40 weeks of gestation
Infant birth weight
Infant birth weight in grams
Time frame: At birth
Infant birth length
Infant birth length in centimetres
Time frame: At birth
Infant Apgar score
Infant Apgar score at 1, 5 and 10 min
Time frame: At birth
Incidence of large-for gestational-age infant
Birth weight \>90th percentile for gestational age and gender
Time frame: At birth
Infant shoulder dystocia
Incidence of infant shoulder dystocia
Time frame: At birth
Infant hypoglycaemia
Incidence of infant hypoglycaemia
Time frame: At birth
Glucose control
Adherence to protocol for daily glucose monitoring (four times per day)
Time frame: From inclusion (baseline) to end of intervention in gestational week 36-37
Glycaemic variability I
Coefficient of variation for glucose excursion over 24 hrs using continous glucose monitoring
Time frame: At the end of the intervention in gestational week 36-37
Glycaemic variability II
Mean for glucose excursion over 24 hrs using continous glucose monitoring
Time frame: At the end of the intervention in gestational week 36-37
Delivery complications
Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)
Time frame: At delivery
Hospital stay
Hospital stay (duration from admission of delivery to discharge) including neonatal care
Time frame: The first week post partum
Glucose- insulin treatment during delivery
Incidence of glucose- insulin treatment during delivery
Time frame: During delivery
Metabolic and inflammatory biomarkers I
Maternal levels of Insulin-like Growth Factor I in serum
Time frame: At gestational weeks 36-37
Metabolic and inflammatory biomarkers II
Maternal levels of Insulin-like Growth Factor I binding proteins in serum
Time frame: At gestational weeks 36-37
Metabolic and inflammatory biomarkers III
Maternal levels of copeptin in serum
Time frame: At gestational week 36-37
Metabolic and inflammatory biomarkers IV
Maternal levels of leptin in serum
Time frame: At gestational week 36-37
Metabolic and inflammatory biomarkers V
Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum
Time frame: At gestational week 36-37
Maternal cardiometabolic risk profile
A maternal cardiometabolic risk profile score one year post partum will be calculated using information on triglycerides and high-density cholesterol in serum, waist circumference, blood glucose as well as the systolic and diastolic blood pressure.
Time frame: One year post partum
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Time frame: One year post partum
Physical activity using accelerometry
Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)
Time frame: One year post partum
Metabolic and inflammatory biomarkers VI
Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum
Time frame: At gestational week 36-37
Glycaemic variability III
Glucose levels using glucose meter (capillary sampling)
Time frame: Full intervention period (up to 3 months)
Microvascular function I
Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Time frame: One year post partum
Microvascular function II
Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Time frame: One year post partum
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