Suzanne Phelan1, Elissa Jelalian2, Donald Coustan3, Aaron B Caughey4, Kristin Castorino5, Todd Hagobian6, Karen Muñoz-Christian7, Andrew Schaffner8, Laurence Shields9, Casey Heaney6, Angelica McHugh10, Rena R Wing10,11. 1. Department of Kinesiology & Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu. 2. Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA. 3. Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA. 4. Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR, USA. 5. Sansum Diabetes Research Institute, Santa Barbara, CA, USA. 6. Department of Kinesiology & Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, CA, USA. 7. Department of World Languages and Cultures, California Polytechnic State University, San Luis Obispo, CA, USA. 8. Statistics Department, California Polytechnic State University, San Luis Obispo, CA, USA. 9. Dignity Health, Marian Regional Medical Center, Santa Maria, CA, USA. 10. Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, USA. 11. Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, USA.
Abstract
BACKGROUND:Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.
RCT Entities:
BACKGROUND:Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.
Authors: Ute M Schaefer-Graf; Thomas A Buchanan; Anny H Xiang; Ruth K Peters; Siri L Kjos Journal: Am J Obstet Gynecol Date: 2002-04 Impact factor: 8.661