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Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled
M L Erickson1, J T Mey1, C L Axelrod2
1Integrative 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.
Insights
Pre-conception lifestyle interventions may reduce neonatal adiposity, breaking the intergenerational obesity cycle. This study investigates a lifestyle program to improve maternal metabolism before pregnancy, aiming for healthier infant outcomes.
Area of Science:
- Reproductive Medicine
- Maternal-Fetal Medicine
- Metabolic Health
Background:
- Maternal obesity is linked to increased neonatal risk for obesity and metabolic syndrome.
- Previous interventions targeting gestational weight gain have not reduced neonatal adiposity.
- Pre-conception lifestyle interventions may improve the in utero environment and fetal development.
Purpose of the Study:
- To evaluate the efficacy of a lifestyle intervention to reduce weight and improve maternal metabolism prior to pregnancy (LIPP) in attenuating neonatal adiposity.
- To compare the LIPP program against standard medical advice for pregnant women.
Main Methods:
- Randomized controlled trial (RCT) with overweight/class 1 obese women preparing for a subsequent pregnancy.
- Participants randomized (1:1) to LIPP or standard care, stratified by lactation status and obesity class.
- LIPP involves intensive short-term weight loss, maintenance, supervised exercise, and a low-glycemic Mediterranean diet.
Main Results:
- Primary outcomes include differences in neonatal adiposity (PEA POD) and placental mitochondrial lipid metabolism.
- Secondary outcomes assess maternal body composition, insulin sensitivity, metabolic biomarkers, and quality of life.
- Exploratory outcomes examine umbilical cord blood insulin resistance, lipid profile, and inflammation.
Conclusions:
- This RCT will provide Level 1 evidence on the effectiveness of pre-conception maternal weight loss interventions.
- Findings could inform standard obstetrical care, improving neonatal outcomes for women planning pregnancy.
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.
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