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

M L Erickson, J T Mey, C L Axelrod, D Paul, L Gordesky, K Russell, H Barkoukis, P O'Tierney-Ginn, R A Fielding, J P Kirwan, P M Catalano

Journal: Contemporary clinical trials 2021;94():106024

PMID: 32389808

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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.

Address: Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.; Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.; Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.; Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.; Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.; Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.; Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: [email protected].; Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: [email protected].

DOI: 10.1016/j.cct.2020.106024

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MeSH Terms: Female, Gestational Weight Gain, Humans, Life Style, Overweight, Pregnancy, Pregnancy Complications, Prenatal Care, Weight Gain