Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
NCT ID: NCT02890693
Last Updated: 2022-11-03
Study Results
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Basic Information
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COMPLETED
NA
211 participants
INTERVENTIONAL
2016-09-30
2021-10-25
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Jardena Puder
Professor
Principal Investigators
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Jardena Puder, MD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Antje Horsch, DClinPsych
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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University Hospital Lausanne
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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Quansah DY, Gilbert L, Arhab A, Gonzalez-Rodriguez E, Hans D, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ. Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial. BMJ Med. 2024 Feb 7;3(1):e000588. doi: 10.1136/bmjmed-2023-000588. eCollection 2024.
Gilbert L, Quansah DY, Arhab A, Schenk S, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ; MySweetheart Research group. Effect of the MySweetheart randomized controlled trial on birth, anthropometric and psychobehavioral outcomes in offspring of women with GDM. Front Endocrinol (Lausanne). 2023 Jun 7;14:1148426. doi: 10.3389/fendo.2023.1148426. eCollection 2023.
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.
Other Identifiers
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2016-00745
Identifier Type: -
Identifier Source: org_study_id
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