Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial

Abstract

Introduction: Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice.

Material and methods: Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet.

Primary outcomes: Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism.

Secondary outcomes: Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation.

Discussion: This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.

Clinical trial registration: NCT03146156.

Keywords: Fetal adiposity; Gestational weight gain; Lifestyle intervention; Maternal obesity; Mediterranean diet; Postpartum; Postpartum weight loss; Pregnancy.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Figure 1 Caption.

The lifestyle intervention in preparation for pregnancy (LIPP) study design. 200 women approximately 12 weeks postpartum, classified as overweight or class I obesity prior to their most recent pregnancy, will be prospectively randomized (1:1) in blocks of 4 to receive either the LIPP or standard of care treatment. The LIPP program consists of 3 months of intensive weight loss, followed by weight loss maintenance lasting until their subsequent pregnancy. Maternal outcome assessments will occur at 3, 6, 9, 15, and 21 months postpartum. Both LIPP and standard of care participants will receive routine clinical management for maternal and gestational health during their subsequent pregnancy. Maternal outcome assessments will occur at 12–16 and 32–36 weeks of gestation. Neonatal body composition will be determined within 72 hours of birth upon delivery.