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

This study is currently recruiting participants.
Verified August 2016 by Jardena Puder, University of Lausanne Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02890693
First Posted: September 7, 2016
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
  Purpose

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.


Condition Intervention
Gestational Diabetes Mellitus Behavioral: interdisciplinary lifestyle and psychosocial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial

Resource links provided by NLM:


Further study details as provided by Jardena Puder, University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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

  • 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 Outcome Measures:
  • 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) ]
  • Skinfolds (mother and infant) measured by calipers [ Time Frame: 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) [ Time Frame: 1 year postpartum ]
  • Self-reported food intake (mother) measured by Food Frequency Questionnaire [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported eating behavior (mother) measured by French Intuitive Eating Scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported breastfeeding (mother) measured by questionnaire [ Time Frame: 6-8- weeks postpartum, 1 year postpartum ]
  • Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire [ Time Frame: 1 year postpartum ]
  • Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire [ Time Frame: 1 year postpartum ]
  • Physical activity (mother) measured by Accelerometer [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Aerobic fitness (mother) measured by Chester Step Test [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Grip strength (mother) measured by Jamar dynamometer [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • 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 ]
  • 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 ]
  • Weight (infant) measured on calibrated scale [ Time Frame: 6-8 weeks postpartum, 1 year postpartum ]
  • Laboratory variables (mother): Lipid levels [ Time Frame: 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 [ 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

  • Cord blood sample at the time of delivery for lipid levels [ Time Frame: At delivery ]
  • Cord blood sample at the time of delivery for glucose control [ Time Frame: At delivery ]
  • Cord blood sample at the time of delivery for insulin indices [ Time Frame: At delivery ]
  • Cord blood sample at the time of delivery for Ferritin and Vitamin B12 [ Time Frame: At delivery ]
  • Cord blood sample at the time of delivery for miRNA [ Time Frame: At delivery ]
  • 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

  • Laboratory (mother): gamma-GT, B12 vitamin, ferritine [ Time Frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum ]
  • Laboratory (mother): miRNA [ Time Frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum ]

Other Outcome Measures:
  • Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index [ Time Frame: study inclusion after GDM diagnosis ]
  • Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form [ Time Frame: 1 year postpartum ]
  • Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire) [ Time Frame: 1 year postpartum ]
  • Weight of partner measured on calibrated scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported eating behavior (partner) measured by French Intuitive Eating Scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported well-being (partner) measured by WHO Well-being Index [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported symptoms of depression (partner) measured by Edinburgh Postnatal Depression Scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • Self-reported anxiety (partner) measured by Hospital Anxiety and Depression Scale [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]
  • 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 ]
  • Self-reported parenting stress (partner) measured by Parenting Stress Scale-short form [ Time Frame: 1 year postpartum ]
  • Self-reported life events (mother, partner) measured by Life Events Questionnaire [ Time Frame: study inclusion after GDM diagnosis, 1 year postpartum ]

Estimated Enrollment: 200
Study Start Date: September 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890693


Contacts
Contact: Jardena Puder, MD +41213140638 jardena.puder@chuv.ch
Contact: Antje Horsch, DClinPsych. +41795560750 antje.horsch@chuv.ch

Locations
Switzerland
University Hospital Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Jardena Puder, MD    +41213140638    jardena.puder@chuv.ch   
Contact: Antje Horsch, DClinPsych    +41795560750    antje.horsch@chuv.ch   
Principal Investigator: Jardena Puder, MD         
Principal Investigator: Antje Horsch, DClinPsych         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Jardena Puder, MD University of Lausanne Hospitals
Principal Investigator: Antje Horsch, DClinPsych University of Lausanne Hospitals
  More Information

Responsible Party: Jardena Puder, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02890693     History of Changes
Other Study ID Numbers: 2016-00745
First Submitted: August 5, 2016
First Posted: September 7, 2016
Last Update Posted: October 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jardena Puder, University of Lausanne Hospitals:
gestational diabetes mellitus
randomized controlled trial
lifestyle intervention
cardiovascular
metabolic
mental health
depression
physical activity
dietary intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications