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

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Gestational Diabetes Mellitus

Treatments: Behavioral: interdisciplinary lifestyle and psychosocial intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02890693

2016-00745

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

interdisciplinary lifestyle/psychosocial

Experimental group

Description:

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.

Treatment:

Behavioral: interdisciplinary lifestyle and psychosocial intervention

treatment as usual

No Intervention group

Description:

Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines.