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

Gestational Diabetes Mellitus Clinical Trial

— MySweetHeart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890693
• Other study ID #: 2016-00745
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: October 25, 2021

Study information

• Verified date: October 2022
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• 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. It will take place during pregnancy and during the first year postpartum.

Locations

Country	Name	City	State
Switzerland	University Hospital Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index		study inclusion after GDM diagnosis
Other	Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form		1 year postpartum
Other	Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)		1 year postpartum
Other	Weight of partner measured on calibrated scale		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported eating behavior (partner) measured by French Intuitive Eating Scale		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported well-being (partner) measured by WHO Well-being Index		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported symptoms of depression (partner) measured by Edinburgh Postnatal Depression Scale		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported anxiety (partner) measured by Hospital Anxiety and Depression Scale		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported social support (partner) measured by Medical Outcomes Study Social Support Survey-short form		study inclusion after GDM diagnosis, 1 year postpartum
Other	Self-reported parenting stress (partner) measured by Parenting Stress Scale-short form		1 year postpartum
Other	Self-reported life events (mother, partner) measured by Life Events Questionnaire		study inclusion after GDM diagnosis, 1 year postpartum
Primary	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
Primary	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	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)
Secondary	Skinfolds (mother and infant) measured by calipers		study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Secondary	Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)		1 year postpartum
Secondary	Self-reported food intake (mother) measured by Food Frequency Questionnaire		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Self-reported eating behavior (mother) measured by French Intuitive Eating Scale		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Self-reported breastfeeding (mother) measured by questionnaire		6-8- weeks postpartum, 1 year postpartum
Secondary	Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire		1 year postpartum
Secondary	Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire		1 year postpartum
Secondary	Physical activity (mother) measured by Accelerometer		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Aerobic fitness (mother) measured by Chester Step Test		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Grip strength (mother) measured by Jamar dynamometer		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	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
Secondary	Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form		study inclusion after GDM diagnosis, 1 year postpartum
Secondary	Weight (infant) measured on calibrated scale		6-8 weeks postpartum, 1 year postpartum
Secondary	Laboratory variables (mother): Lipid levels		study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Secondary	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
Secondary	Cord blood sample at the time of delivery for lipid levels		At delivery
Secondary	Cord blood sample at the time of delivery for glucose control		At delivery
Secondary	Cord blood sample at the time of delivery for insulin indices		At delivery
Secondary	Cord blood sample at the time of delivery for Ferritin and Vitamin B12		At delivery
Secondary	Cord blood sample at the time of delivery for miRNA		At delivery
Secondary	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
Secondary	Laboratory (mother): gamma-GT, B12 vitamin, ferritine		study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Secondary	Laboratory (mother): miRNA		study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum