Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for , a randomised controlled trial.

Antje Horsch, Leah Gilbert, Stefano Lanzi, Justine Gross, Bengt Kayser, Yvan Vial, Umberto Simeoni, Didier Hans, Alexandre Berney, Urte Scholz, Ruben Barakat, Jardena J Puder

Journal: BMJ open 2018;8(2):e020462

PMID: 29487077

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Abstract

INTRODUCTION

Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy.

METHODS AND ANALYSIS

This randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24-32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24-32 weeks of pregnancy, shortly after birth and at 6-8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. The is linked to the (clinicaltrials.gov/ct2/show/NCT02872974).

ETHICS AND DISSEMINATION

We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT02890693; Pre-results.

Address: Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland.; Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland.; Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.; Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.; Service of Angiology, Heart and Vessel Department, Lausanne University Hospital, Lausanne, Switzerland.; Institute of Sport Sciences, University of Lausanne, Lausanne, Switzerland.; Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland.; DOHad Laboratory, Pediatrics Division, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland.; Center of Bone Diseases, Rheumatology Service, Bone and Joint Department, Lausanne University Hospital, Lausanne, Switzerland.; Consultation Liaison Psychiatry, Lausanne University Hospital, Lausanne, Switzerland.; Applied Social and Health Psychology, Department of Psychology, University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Lausanne, Switzerland.; Facultad de Ciencias de la Actividad Física y del Deporte-INEF, Universidad Politécnica de Madrid, Madrid, Spain.; Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland.; Service of Pediatric Endocrinology, Diabetology and Obesity, Lausanne University Hospital, Lausanne, Switzerland.

DOI: 10.1136/bmjopen-2017-020462

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MeSH Terms: Depressive Disorder, Diabetes, Gestational, Diet Therapy, Exercise, Female, Humans, Infant, Infant, Newborn, Life Style, Linear Models, Mental Health, Patient Care Team, Postpartum Period, Pregnancy, Pregnancy Complications, Psychiatric Rehabilitation, Research Design, Self Report, Switzerland