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NCT Number: NCT02890693

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus Behavior Behavioral Symptoms Depression Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Personal Satisfaction Pregnancy Complications Psychological Well-Being Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interdisciplinary lifestyle and psychosocial intervention

Behavioral

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

Primary outcomes

  1. maternal weight measured on calibrated scale

    Time frame: study inclusion after GDM diagnosis and 1 year postpartum

    decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum

  2. Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale

    Time frame: study inclusion after GDM diagnosis and 1 year postpartum

    decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum

Secondary outcomes

  1. Body composition (mother and infant) measured by bioelectrical impedance analysis

    Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)

  2. Skinfolds (mother and infant) measured by calipers

    Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)

  3. Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)

    Time frame: 1 year postpartum

  4. Self-reported food intake (mother) measured by Food Frequency Questionnaire

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  5. Self-reported eating behavior (mother) measured by French Intuitive Eating Scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  6. Self-reported breastfeeding (mother) measured by questionnaire

    Time frame: 6-8- weeks postpartum, 1 year postpartum

  7. Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire

    Time frame: 1 year postpartum

  8. Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire

    Time frame: 1 year postpartum

  9. Physical activity (mother) measured by Accelerometer

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  10. Aerobic fitness (mother) measured by Chester Step Test

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  11. Grip strength (mother) measured by Jamar dynamometer

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  12. Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  13. Self-reported well-being (mother) measured by WHO Well-being Index

    Time frame: study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum

  14. Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  15. Weight (infant) measured on calibrated scale

    Time frame: 6-8 weeks postpartum, 1 year postpartum

  16. Laboratory variables (mother): Lipid levels

    Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

  17. 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

    Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

    Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum

  18. Cord blood sample at the time of delivery for lipid levels

    Time frame: At delivery

  19. Cord blood sample at the time of delivery for glucose control

    Time frame: At delivery

  20. Cord blood sample at the time of delivery for insulin indices

    Time frame: At delivery

  21. Cord blood sample at the time of delivery for Ferritin and Vitamin B12

    Time frame: At delivery

  22. Cord blood sample at the time of delivery for miRNA

    Time frame: At delivery

  23. Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion,

    Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

    Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum

  24. Laboratory (mother): gamma-GT, B12 vitamin, ferritine

    Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

  25. Laboratory (mother): miRNA

    Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

Other outcomes

  1. Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index

    Time frame: study inclusion after GDM diagnosis

  2. Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form

    Time frame: 1 year postpartum

  3. Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)

    Time frame: 1 year postpartum

  4. Weight of partner measured on calibrated scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  5. Self-reported eating behavior (partner) measured by French Intuitive Eating Scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  6. Self-reported well-being (partner) measured by WHO Well-being Index

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  7. Self-reported symptoms of depression (partner) measured by Edinburgh Postnatal Depression Scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  8. Self-reported anxiety (partner) measured by Hospital Anxiety and Depression Scale

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  9. Self-reported social support (partner) measured by Medical Outcomes Study Social Support Survey-short form

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

  10. Self-reported parenting stress (partner) measured by Parenting Stress Scale-short form

    Time frame: 1 year postpartum

  11. Self-reported life events (mother, partner) measured by Life Events Questionnaire

    Time frame: study inclusion after GDM diagnosis, 1 year postpartum

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Acronym: MySweetHeart

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2016
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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