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

NCT02890693 | Completed DMC

• 1 other identifier: 2016-00745
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus

Keywords

gestational diabetes mellitus; randomized controlled trial; lifestyle intervention; cardiovascular; metabolic; mental health; depression; physical activity; dietary intervention

Outcome Measures

Primary Outcomes (2)

• maternal weight measured on calibrated scale

  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

  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 Outcomes (25)

• Body composition (mother and infant) measured by bioelectrical impedance analysis

  study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)

• Skinfolds (mother and infant) measured by calipers

  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)

  1 year postpartum

• Self-reported food intake (mother) measured by Food Frequency Questionnaire

  study inclusion after GDM diagnosis, 1 year postpartum

• Self-reported eating behavior (mother) measured by French Intuitive Eating Scale

  study inclusion after GDM diagnosis, 1 year postpartum

Other Outcomes (11)

• Self-reported sleep quality and quantity (mother) measured by Pittsburgh Sleep Quality Index

  study inclusion after GDM diagnosis

• Self-reported parenting stress (mother) measured by Parenting Stress Scale-short form

  1 year postpartum

• Sleep quality and quantity of the infant measured by maternal self-report (Brief Infant Sleep Questionnaire)

  1 year postpartum

Study Arms (2)

interdisciplinary lifestyle/psychosocial

EXPERIMENTAL

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

treatment as usual

NO INTERVENTION

Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines.

Interventions

interdisciplinary lifestyle and psychosocial intervention BEHAVIORAL

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.

Also known as: lifestyle intervention, physical activity, dietary intervention, psychosocial intervention

interdisciplinary lifestyle/psychosocial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.

You may not qualify if:

• Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (4)

• 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: 38348309 DERIVED

• 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: 37351105 DERIVED

• 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: 29487077 DERIVED

• 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.

  PMID: 29138200 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Psychological Well-Being; Depression; Motor Activity

Interventions

Psychosocial Intervention; Exercise; Diet Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Jardena Puder, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

• Antje Horsch, DClinPsych

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

CH (1)