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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Diane C Berry, Madeline Neal, Emily G Hall, Todd A Schwartz, Sarah Verbiest, Karen Bonuck, William Goodnight, Seth Brody, Karen F Dorman, Mary K Menard, Alison M Stuebe

Published in: BMC Pregnancy and Childbirth | Issue 1/2013

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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
Appendix
Available only for authorised users
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Metadata
Title
Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study
Authors
Diane C Berry
Madeline Neal
Emily G Hall
Todd A Schwartz
Sarah Verbiest
Karen Bonuck
William Goodnight
Seth Brody
Karen F Dorman
Mary K Menard
Alison M Stuebe
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2013
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-13-184

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