Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT02890693
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2016-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'measure': 'maternal weight measured on calibrated scale', 'timeFrame': 'study inclusion after GDM diagnosis and 1 year postpartum', 'description': 'decrease in maternal weight between 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', 'description': 'decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum'}], 'secondaryOutcomes': [{'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', 'description': 'Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 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', 'description': 'Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gestational diabetes mellitus', 'randomized controlled trial', 'lifestyle intervention', 'cardiovascular', 'metabolic', 'mental health', 'depression', 'physical activity', 'dietary intervention'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38348309', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37351105', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29487077', 'type': 'DERIVED', '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.'}, {'pmid': '29138200', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary objective of MySweetHeart Trial:\n\nTo 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).\n\nSecondary objective of MySweetHeart Trial:\n\nTo 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.\n\nMySweetHeart 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.\n\nExclusion Criteria:\n\n* Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.'}, 'identificationModule': {'nctId': 'NCT02890693', 'acronym': 'MySweetHeart', 'briefTitle': 'Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial', 'orgStudyIdInfo': {'id': '2016-00745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interdisciplinary lifestyle/psychosocial', 'description': '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.', 'interventionNames': ['Behavioral: interdisciplinary lifestyle and psychosocial intervention']}, {'type': 'NO_INTERVENTION', 'label': 'treatment as usual', 'description': 'Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines.'}], 'interventions': [{'name': 'interdisciplinary lifestyle and psychosocial intervention', 'type': 'BEHAVIORAL', 'otherNames': ['lifestyle intervention', 'physical activity', 'dietary intervention', 'psychosocial intervention'], 'description': '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.', 'armGroupLabels': ['interdisciplinary lifestyle/psychosocial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'University Hospital Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Jardena Puder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne Hospitals'}, {'name': 'Antje Horsch, DClinPsych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jardena Puder', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}