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

October 31, 2022 updated by: Jardena Puder, University of Lausanne Hospitals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
study inclusion after GDM diagnosis and 1 year postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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
1 year postpartum
Self-reported food intake (mother) measured by Food Frequency Questionnaire
Time Frame: study inclusion after GDM diagnosis, 1 year postpartum
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
study inclusion after GDM diagnosis, 1 year postpartum
Self-reported breastfeeding (mother) measured by questionnaire
Time Frame: 6-8- weeks postpartum, 1 year postpartum
6-8- weeks postpartum, 1 year postpartum
Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire
Time Frame: 1 year postpartum
1 year postpartum
Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire
Time Frame: 1 year postpartum
1 year postpartum
Physical activity (mother) measured by Accelerometer
Time Frame: study inclusion after GDM diagnosis, 1 year postpartum
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
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
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
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
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
study inclusion after GDM diagnosis, 1 year postpartum
Weight (infant) measured on calibrated scale
Time Frame: 6-8 weeks postpartum, 1 year postpartum
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
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
study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cord blood sample at the time of delivery for lipid levels
Time Frame: At delivery
At delivery
Cord blood sample at the time of delivery for glucose control
Time Frame: At delivery
At delivery
Cord blood sample at the time of delivery for insulin indices
Time Frame: At delivery
At delivery
Cord blood sample at the time of delivery for Ferritin and Vitamin B12
Time Frame: At delivery
At delivery
Cord blood sample at the time of delivery for miRNA
Time Frame: At delivery
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
study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): gamma-GT, B12 vitamin, ferritine
Time Frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
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
study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index
Time Frame: study inclusion after GDM diagnosis
study inclusion after GDM diagnosis
Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form
Time Frame: 1 year postpartum
1 year postpartum
Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)
Time Frame: 1 year postpartum
1 year postpartum
Weight of partner measured on calibrated scale
Time Frame: study inclusion after GDM diagnosis, 1 year postpartum
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
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
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
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
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
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
1 year postpartum
Self-reported life events (mother, partner) measured by Life Events Questionnaire
Time Frame: study inclusion after GDM diagnosis, 1 year postpartum
study inclusion after GDM diagnosis, 1 year postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lausanne Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jardena Puder, MD, University of Lausanne Hospitals
  • Principal Investigator: Antje Horsch, DClinPsych, University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-00745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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