Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional

Abstract Background Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of and cesarean delivery as well increased long-term risks type 2 diabetes, metabolic syndrome, cardiovascular disease. Intrauterine exposure to GDM raises the risk offspring well, stillbirth, macrosomia, birth trauma, One strongest factors occurrence a prior pregnancy. Preliminary data from epidemiologic bariatric surgery studies suggest that reducing body weight before pregnancy can prevent development GDM, but no adequately powered trial has tested effects lifestyle intervention reduce recurrence. Methods The principal aim Diabetes Prevention/Prevención de la Gestacional determine whether This two-site targets recruitment 252 women overweight obesity who have previous histories plan another next 1–3 years. Women are randomized within site comprehensive pre-pregnancy promote loss ongoing treatment until conception or an educational control group. Participants assessed preconceptionally (at study entry, after 4 months, at brief quarterly visits conception), during 26 weeks’ gestation), 6 weeks postpartum. primary outcome recurrence, secondary outcomes include fasting glucose, biomarkers cardiometabolic disease, prenatal perinatal complications, changes over time weight, diet, physical activity, psychosocial measures. Discussion Prevention /Prevención first controlled evaluate delivered If found effective, proposed could lay groundwork shifting current practices towards interconception period provide evidence-based preconception counseling optimize reproductive health risks. Trial registration ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016