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Trial record 48 of 224 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT02890693
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals

August 5, 2016
September 7, 2016
October 11, 2016
September 2016
September 2020   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02890693 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gestational Diabetes Mellitus
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
  • 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.
    Intervention: Behavioral: interdisciplinary lifestyle and 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
September 2020
September 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Jardena Puder, MD +41213140638 jardena.puder@chuv.ch
Contact: Antje Horsch, DClinPsych. +41795560750 antje.horsch@chuv.ch
Switzerland
 
 
NCT02890693
2016-00745
Yes
Not Provided
Plan to Share IPD: Undecided
Jardena Puder, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Principal Investigator: Jardena Puder, MD University of Lausanne Hospitals
Principal Investigator: Antje Horsch, DClinPsych University of Lausanne Hospitals
University of Lausanne Hospitals
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP