Clinical trial NCT02890693: Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
Official title: Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: gestational diabetes mellitus
randomized controlled trial
lifestyle intervention
cardiovascular
metabolic
mental health
depression
physical activity
dietary intervention
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: maternal weight measured on calibrated scale
timeFrame: study inclusion after GDM diagnosis and 1 year postpartum
measure: Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale
timeFrame: study inclusion after GDM diagnosis and 1 year postpartum
Secondary outcomes:
measure: Body composition (mother and infant) measured by bioelectrical impedance analysis
timeFrame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
measure: Skinfolds (mother and infant) measured by calipers
timeFrame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
measure: Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)
timeFrame: 1 year postpartum
measure: Self-reported food intake (mother) measured by Food Frequency Questionnaire
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported eating behavior (mother) measured by French Intuitive Eating Scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported breastfeeding (mother) measured by questionnaire
timeFrame: 6-8- weeks postpartum, 1 year postpartum
measure: Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire
timeFrame: 1 year postpartum
measure: Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire
timeFrame: 1 year postpartum
measure: Physical activity (mother) measured by Accelerometer
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Aerobic fitness (mother) measured by Chester Step Test
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Grip strength (mother) measured by Jamar dynamometer
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported well-being (mother) measured by WHO Well-being Index
timeFrame: study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum
measure: Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Weight (infant) measured on calibrated scale
timeFrame: 6-8 weeks postpartum, 1 year postpartum
measure: Laboratory variables (mother): Lipid levels
timeFrame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
measure: 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
timeFrame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
measure: Cord blood sample at the time of delivery for lipid levels
timeFrame: At delivery
measure: Cord blood sample at the time of delivery for glucose control
timeFrame: At delivery
measure: Cord blood sample at the time of delivery for insulin indices
timeFrame: At delivery
measure: Cord blood sample at the time of delivery for Ferritin and Vitamin B12
timeFrame: At delivery
measure: Cord blood sample at the time of delivery for miRNA
timeFrame: At delivery
measure: Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion,
timeFrame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
measure: Laboratory (mother): gamma-GT, B12 vitamin, ferritine
timeFrame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
measure: Laboratory (mother): miRNA
timeFrame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Other outcomes:
measure: Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index
timeFrame: study inclusion after GDM diagnosis
measure: Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form
timeFrame: 1 year postpartum
measure: Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)
timeFrame: 1 year postpartum
measure: Weight of partner measured on calibrated scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported eating behavior (partner) measured by French Intuitive Eating Scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported well-being (partner) measured by WHO Well-being Index
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported symptoms of depression (partner) measured by Edinburgh Postnatal Depression Scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported anxiety (partner) measured by Hospital Anxiety and Depression Scale
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported social support (partner) measured by Medical Outcomes Study Social Support Survey-short form
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
measure: Self-reported parenting stress (partner) measured by Parenting Stress Scale-short form
timeFrame: 1 year postpartum
measure: Self-reported life events (mother, partner) measured by Life Events Questionnaire
timeFrame: study inclusion after GDM diagnosis, 1 year postpartum
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Jardena Puder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne Hospitals
name: Antje Horsch, DClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.