Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Behavioral: interdisciplinary lifestyle and psychosocial intervention
- Registration Number
- NCT02890693
- Lead Sponsor
- University of Lausanne Hospitals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.
- Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description interdisciplinary lifestyle/psychosocial interdisciplinary lifestyle and psychosocial intervention 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.
- Primary Outcome Measures
Name Time Method Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale study inclusion after GDM diagnosis and 1 year postpartum decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum
maternal weight measured on calibrated scale study inclusion after GDM diagnosis and 1 year postpartum decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum
- Secondary Outcome Measures
Name Time Method Laboratory variables (mother): Lipid levels study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale study inclusion after GDM diagnosis, 1 year postpartum Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire 1 year postpartum Physical activity (mother) measured by Accelerometer study inclusion after GDM diagnosis, 1 year postpartum Aerobic fitness (mother) measured by Chester Step Test study inclusion after GDM diagnosis, 1 year postpartum Grip strength (mother) measured by Jamar dynamometer study inclusion after GDM diagnosis, 1 year postpartum Self-reported well-being (mother) measured by WHO Well-being Index study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum Self-reported breastfeeding (mother) measured by questionnaire 6-8- weeks postpartum, 1 year postpartum Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire 1 year postpartum Weight (infant) measured on calibrated scale 6-8 weeks postpartum, 1 year postpartum Self-reported eating behavior (mother) measured by French Intuitive Eating Scale study inclusion after GDM diagnosis, 1 year postpartum Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form study inclusion after GDM diagnosis, 1 year postpartum Body composition (mother and infant) measured by bioelectrical impedance analysis study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant) Skinfolds (mother and infant) measured by calipers 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) 1 year postpartum Self-reported food intake (mother) measured by Food Frequency Questionnaire study inclusion after GDM diagnosis, 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 study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Cord blood sample at the time of delivery for lipid levels At delivery Cord blood sample at the time of delivery for glucose control At delivery Cord blood sample at the time of delivery for insulin indices At delivery Cord blood sample at the time of delivery for Ferritin and Vitamin B12 At delivery Cord blood sample at the time of delivery for miRNA At delivery Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion, study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Laboratory (mother): gamma-GT, B12 vitamin, ferritine study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum Laboratory (mother): miRNA study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Trial Locations
- Locations (1)
University Hospital Lausanne
🇨ðŸ‡Lausanne, Vaud, Switzerland