Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring

Study Overview
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Brief Summary
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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.

Official Title
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Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Behavioral: interdisciplinary lifestyle and psychosocial intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interdisciplinary lifestyle/psychosocial<br>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. | Behavioral: interdisciplinary lifestyle and psychosocial intervention<br>* 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.<br>* Other names: psychosocial intervention;|
| No Intervention: treatment as usual<br>Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal weight measured on calibrated scale | decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum | 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 | study inclusion after GDM diagnosis and 1 year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 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 | 
| 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 | Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum | study inclusion after GDM diagnosis, 6-8 weeks postpartum, 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, | Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum | study inclusion after GDM diagnosis, 6-8 weeks postpartum, 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic, gestational diabetes mellitus, randomized controlled trial, lifestyle intervention, cardiovascular, mental health, depression, physical activity, dietary intervention