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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: interdisciplinary lifestyle and psychosocial intervention

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • University Hospital Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interdisciplinary lifestyle/psychosocial; 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; 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.; Other Names: lifestyle intervention; physical activity; dietary intervention; psychosocial intervention
No Intervention: treatment as usual; 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?

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

Other Outcome Measures

Outcome Measure	Time Frame
Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index	study inclusion after GDM diagnosis
Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form	1 year postpartum
Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)	1 year postpartum
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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Jardena Puder, MD, University of Lausanne Hospitals; Principal Investigator: Antje Horsch, DClinPsych, University of Lausanne Hospitals

Publications and helpful links

General Publications

• Horsch A, Gilbert L, Lanzi S, Gross J, Kayser B, Vial Y, Simeoni U, Hans D, Berney A, Scholz U, Barakat R, Puder JJ; MySweetHeart Research Group. Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e020462. doi: 10.1136/bmjopen-2017-020462.
• Di Bernardo S, Mivelaz Y, Epure AM, Vial Y, Simeoni U, Bovet P, Estoppey Younes S, Chiolero A, Sekarski N; MySweetHeart Research Group. Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland. BMJ Open. 2017 Nov 14;7(11):e016972. doi: 10.1136/bmjopen-2017-016972.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; randomized controlled trial; depression; mental health; lifestyle intervention; cardiovascular; dietary intervention; gestational diabetes mellitus; metabolic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 2016-00745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided