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

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.

Figure 1

Flow-chart. (A) For the outcomes: hospitalization at birth, hyperbilirubinemia and hypoglycaemia, we were able to retrieve information from the other hospitals to analyse the data on 211 individuals. We were also able to retrieve birth length for 4 individuals, thus length analyses was made on 208 individuals. (B) For two separate individuals one length and one size was missing, bringing the numbers down from 197 to 196 for weight and length and to 195 for BMI and z-scores. Also, we were unable to conduct skinfolds on 7 individuals. (C) One individual did not have his weight and length measured, thus why there are 175 individuals for these measures. We did not measure 13 individuals for their skinfolds and BIA, mostly due to maternal choice which left us with 163 individuals for both measures. Finally, at one year only 153 mothers filled out the Difficult Child Indicator Scale and only 161 mothers filled out the Brief Infant Sleep Questionnaire, in which one mother omitted to answer the total nighttime sleep duration and the number of night wakings.