Gestational Diabetes Mellitus
Conditions
Keywords
gestational diabetes mellitus, randomized controlled trial, lifestyle intervention, cardiovascular, metabolic, mental health, depression, physical activity, dietary intervention
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.
Interventions
BEHAVIORALinterdisciplinary 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. It will take place during pregnancy and during the first year postpartum.
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.
Exclusion criteria
* Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity (mother) measured by Accelerometer | study inclusion after GDM diagnosis, 1 year postpartum | — |
| Weight (infant) measured on calibrated scale | 6-8 weeks postpartum, 1 year postpartum | — |
| Laboratory variables (mother): Lipid levels | 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 | 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 | — |
| Self-reported food intake (mother) measured by Food Frequency Questionnaire | study inclusion after GDM diagnosis, 1 year postpartum | — |
| Skinfolds (mother and infant) measured by calipers | study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant) | — |
| 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) | — |
| Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother) | 1 year postpartum | — |
| Self-reported eating behavior (mother) measured by French Intuitive Eating Scale | study inclusion after GDM diagnosis, 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 | — |
| Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire | 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 anxiety (mother) measured by Hospital Anxiety and Depression Scale | 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 social support (mother) measured by Medical Outcomes Study Social Support Survey-short form | study inclusion after GDM diagnosis, 1 year postpartum | — |
Other
| Measure | Time frame |
|---|---|
| Weight of partner measured on calibrated scale | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported eating behavior (partner) measured by French Intuitive Eating Scale | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported well-being (partner) measured by WHO Well-being Index | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported symptoms of depression (partner) measured by Edinburgh Postnatal Depression Scale | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported anxiety (partner) measured by Hospital Anxiety and Depression Scale | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported social support (partner) measured by Medical Outcomes Study Social Support Survey-short form | study inclusion after GDM diagnosis, 1 year postpartum |
| Self-reported parenting stress (partner) measured by Parenting Stress Scale-short form | 1 year postpartum |
| Self-reported life events (mother, partner) measured by Life Events Questionnaire | study inclusion after GDM diagnosis, 1 year postpartum |
| Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire) | 1 year postpartum |
| Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form | 1 year postpartum |
| Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index | study inclusion after GDM diagnosis |
Countries
Switzerland
Outcome results
None listed