Effect of the MySweetheart randomized controlled trial on birth, anthropometric and psychobehavioral outcomes in offspring of women with GDM

Leah Gilbert; Dan Yedu Quansah; Amar Arhab; Sybille Schenk; Justine Gross; Stefano Lanzi; Bobby Stuijfzand; Alain Lacroix; Antje Horsch; Jardena J Puder; MySweetheart Research group

doi:10.3389/fendo.2023.1148426

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.

Authors

Affiliations

¹ Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
² Obstetric Service, Department Woman-Mother-Child, Interdisciplinary GDM Group Lausanne, Lausanne University Hospital, Lausanne, Switzerland.
³ Service d'angiologie, Département Cœur-Vaisseaux, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
⁴ Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland.
⁵ Neonatology Service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland.

Abstract

Introduction: Gestational diabetes mellitus (GDM) may negatively affect offspring outcomes. A lifestyle intervention may therefore not only improve maternal, but also offspring outcomes. The effects of lifestyle interventions on birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM need further evidence.

Design: The MySweetheart trial is a monocentric single-blind randomized controlled trial in 211 women with GDM. It tested the effect of a pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention focusing on both the mothers and their infants and its effects on maternal (primary outcomes) and offspring (secondary outcomes) metabolic and psychobehavioral outcomes compared with guidelines-based usual-care. This paper focuses on offspring's birth, anthropometric, and maternal report of psychobehavioral outcomes at singular timepoints.

Methods: Women with GDM aged ≥18 years, between 24-32 weeks of gestation, speaking French or English were included and randomly allocated to either the intervention or to an active guidelines-based usual-care group using a 1:1 allocation ratio. The intervention lasted from pregnancy until 1 year postpartum and focused on improving diet, physical activity, and mental health in the mother. For the offspring it focused on supporting breastfeeding, delaying the timing of introduction of solid foods, reducing the consumption of sweetened beverages, increasing physical activity of the family, and improving parental responsiveness to infant distress, hunger, satiety and sleeping cues, and difficult behavior.

Results: Adverse birth and neonatal outcomes rarely occurred overall. There were no differences between groups in offspring birth, neonatal, anthropometric, or psychobehavioral outcomes up to one year. After adjustments for maternal age and the offspring's sex and age, there was a borderline significant between-group difference in birth length (β:-0.64, CI:-1.27; -0.01, p: 0.05), i.e., offspring of mothers in the intervention group were born 0.64 cm shorter compared to those in the usual-care group.

Conclusion: This is the first pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention in GDM focusing on both the mother and the offspring. It did not lead to a significant improvement in most birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM. ClinicalTrials.gov Identifier: NCT02890693.

Keywords: BMI - body mass index; fat mass; hypoglycemia; prematurity; skinfold; sleep; temperament; weight.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Body Mass Index
Diabetes, Gestational*
Female
Humans
Infant
Infant, Newborn
Parturition
Postpartum Period
Pregnancy
Single-Blind Method

Associated data

ClinicalTrials.gov/NCT02890693

Grants and funding

This study was supported by a project grant from the Swiss National Science Foundation (SNF 32003B_176119 PIs: JP & AH) and by an unrestricted educational grant from Novo Nordisk. The SNF and Novo Nordisk had no role regarding the content of the original data or analyses or in the drafting of this manuscript. AH is a board member of the COST Action CA18211.