MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring. Primary objective of MySweetHeart Trial: To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention in women with GDM to improve 1) their metabolic health (decrease in maternal weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their mental health (decrease in maternal symptoms of depression during the same time period). Secondary objective of MySweetHeart Trial: To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve other cardio-metabolic and mental health markers in women with GDM and their offspring. MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that assesses the effect of GDM on offspring cardiovascular health early in life. The principal investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
211
The multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. It will take place during pregnancy and during the first year postpartum.
University Hospital Lausanne
Lausanne, Canton of Vaud, Switzerland
maternal weight measured on calibrated scale
decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum
Time frame: study inclusion after GDM diagnosis and 1 year postpartum
Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale
decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum
Time frame: study inclusion after GDM diagnosis and 1 year postpartum
Body composition (mother and infant) measured by bioelectrical impedance analysis
Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Skinfolds (mother and infant) measured by calipers
Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)
Time frame: 1 year postpartum
Self-reported food intake (mother) measured by Food Frequency Questionnaire
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported eating behavior (mother) measured by French Intuitive Eating Scale
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported breastfeeding (mother) measured by questionnaire
Time frame: 6-8- weeks postpartum, 1 year postpartum
Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire
Time frame: 1 year postpartum
Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire
Time frame: 1 year postpartum
Physical activity (mother) measured by Accelerometer
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Aerobic fitness (mother) measured by Chester Step Test
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Grip strength (mother) measured by Jamar dynamometer
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported well-being (mother) measured by WHO Well-being Index
Time frame: study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum
Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Weight (infant) measured on calibrated scale
Time frame: 6-8 weeks postpartum, 1 year postpartum
Laboratory variables (mother): Lipid levels
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cardiometabolic laboratory variables (mother), HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, HbA1C, insulin, glucose, indices of insulin resistance and insulin secretion, gamma-GT, B12 vitamin, ferritine, and miRNA
Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cord blood sample at the time of delivery for lipid levels
Time frame: At delivery
Cord blood sample at the time of delivery for glucose control
Time frame: At delivery
Cord blood sample at the time of delivery for insulin indices
Time frame: At delivery
Cord blood sample at the time of delivery for Ferritin and Vitamin B12
Time frame: At delivery
Cord blood sample at the time of delivery for miRNA
Time frame: At delivery
Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion,
Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): gamma-GT, B12 vitamin, ferritine
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): miRNA
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
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