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

Horsch, Antje; Gilbert, Leah; Lanzi, Stefano; Gross, Justine; Kayser, Bengt; Vial, Yvan; Simeoni, Umberto; Hans, Didier; Berney, Alexandre; Scholz, Urte; Barakat, Ruben; Puder, Jardena J (2018). Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for, a randomised controlled trial. BMJ Open, 8(2):e020462.

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.

Additional indexing

Contributors:MySweetHeart Research Group
Item Type:Journal Article, refereed, original work
Communities & Collections:06 Faculty of Arts > Institute of Psychology
08 Research Priority Programs > Dynamics of Healthy Aging
Dewey Decimal Classification:150 Psychology
Scopus Subject Areas:Health Sciences > General Medicine
Language:English
Date:27 February 2018
Deposited On:09 Oct 2018 14:04
Last Modified:19 Jan 2025 02:40
Publisher:BMJ Publishing Group
ISSN:2044-6055
OA Status:Gold
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1136/bmjopen-2017-020462
PubMed ID:29487077
Project Information:
  • Funder: SNSF
  • Grant ID: 32003B_176119
  • Project Title: Improving metabolic and mental health in women with gestational diabetes and their offspring
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