TY - JOUR
T1 - Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes
T2 - Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional
AU - Phelan, Suzanne
AU - Jelalian, Elissa
AU - Coustan, Donald
AU - Caughey, Aaron B.
AU - Castorino, Kristin
AU - Hagobian, Todd
AU - Muñoz-Christian, Karen
AU - Schaffner, Andrew
AU - Shields, Laurence
AU - Heaney, Casey
AU - McHugh, Angelica
AU - Wing, Rena R.
N1 - Funding Information:
This study was funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development grant R01HD084282. The funding body had no role in the design, data collection and analysis, decision to publish, or preparation of this manuscript.
Funding Information:
SP and RW conceived and designed the research and helped draft the manuscript. DC, KC, AC, TH, AS, RW, EJ, SP, KMC, LS, CH, and AM participated in the design and coordination of the study and data acquisition methods and helped draft the manuscript. EJ, SP, RW, CH, and AM participated in the design and development of the intervention. AS developed the statistical analyses and power calculations. CH, AM, and TH participated in the design of the visits. All authors read and approved the final manuscript. This study was funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development grant R01HD084282. The funding body had no role in the design, data collection and analysis, decision to publish, or preparation of this manuscript. The principal investigator and co-investigators will have access to the final trial data set. Any data required to support the protocol can be supplied on request.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Gestational diabetes
KW - Lifestyle intervention
KW - Preconception weight loss
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85104023586&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104023586&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05204-w
DO - 10.1186/s13063-021-05204-w
M3 - Article
C2 - 33827659
AN - SCOPUS:85104023586
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 256
ER -