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Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

ABSTRACT: Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina.Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting.Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations.NCT01809431.

SUBMITTER: Berry DC

PROVIDER: S-EPMC3907028 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

Berry Diane C DC Neal Madeline M Hall Emily G EG Schwartz Todd A TA Verbiest Sarah S Bonuck Karen K Goodnight William W Brody Seth S Dorman Karen F KF Menard Mary K MK Stuebe Alison M AM

BMC pregnancy and childbirth 20131010

<h4>Background</h4>Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina.<h4>Methods/design</h4>Using a two-group, repeated meas ...[more]

PMID: 24112417

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Project description:OBJECTIVES: To assess the maternal and fetal complications of pregnancy in mothers with gestational diabetes mellitus (GDM) compared with non-diabetic patients who delivered in the hospital during the study period. METHODS: The outcome of pregnancy in 220 Saudi patients with GDM identified from the delivery register/hospital database and matched for age, parity and body mass index with 220 non-diabetic controls were studied retrospectively from their case files. Patients with multiple pregnancies and abnormal presentation of the fetus were excluded from the study. RESULTS: The GDM patients were treated with either diet alone or with additional insulin in some patients who required better control of their blood sugar levels. Patients with GDM had a significantly higher incidence of pre-eclampsia (p<0.0001); preterm delivery (p=0.0226); induction of labor (p<0.0001); cesarean section (p=0.0019); higher mean birth weight (p<0.0001) of babies; large for gestational age infants (p=0.0011); macrosomia (p=0.0186); and admission to the neonatal intensive care unit (p=0.0003), compared with the control group. However, the rates of Apgar score <7 at 5 minutes, respiratory distress syndrome, neonatal hypoglycemia, hyperbilirubinemia and the need for phototherapy were similar in both groups of patients. Congenital anomalies and perinatal mortality rates were not significantly different in the two groups. CONCLUSION: GDM is recognized to be associated with increased rates of adverse maternal and neonatal outcomes, which are supported by the findings of this study. Even the mild form of GDM seems to have significant consequences for women and their offspring and is recommended to be aggressively treated. Evidence suggests that early diagnosis and strict control of blood sugar levels throughout the pregnancy can significantly reduce maternal and fetal complications. A multicenter, randomized controlled trial, based on universally accepted criteria for GDM screening test, standardized diagnostic OGTT and management of all patients with GDM versus the standard obstetric management of the control is warranted.

Project description:BackgroundWomen with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.Methods/designThe GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).DiscussionThere is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.

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Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

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Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

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