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Open Access Study protocol

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

Diane C Berry1*, Madeline Neal1, Emily G Hall1, Todd A Schwartz1, Sarah Verbiest2, Karen Bonuck34, William Goodnight25, Seth Brody26, Karen F Dorman2, Mary K Menard2 and Alison M Stuebe27

Author Affiliations

1 School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill 27599-7460, NC, USA

2 Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, 3010 Old Clinic Building, Campus Box 7516, Chapel Hill 27599-7516, NC, USA

3 Department of Family and Social Medicine, Albert Einstein College of Medicine, Rochester 14602, NY, USA

4 Department of Obstetrics, Gynecology & Women’s Health, 1300 Morris Park Avenue, Bronx 10461, NY, USA

5 Rex Healthcare Inc, OB/GYN, 4420 Lake Boone Trail, Raleigh 27607, NC, USA

6 WakeMed Health & Hospitals, WakeMed Faculty Physicians, OB/GYN, 3024 New Bern Avenue, Raleigh 27610, NC, USA

7 Department of Maternal and Child Health, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, 170 Rosenau Hall, Campus Box 7400, Chapel Hill 27599-7400, NC, USA

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BMC Pregnancy and Childbirth 2013, 13:184  doi:10.1186/1471-2393-13-184

Published: 10 October 2013

Abstract

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

NCT01809431