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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.
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.
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