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

Gestational Diabetes Mellitus Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02890693
Study type Interventional
Source University of Lausanne Hospitals
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date October 25, 2021
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