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

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Creator
  • Berry, Diane
    • Affiliation: School of Nursing
  • Neal, Madeline N
    • Affiliation: School of Nursing
  • Hall, Emily G.
    • Affiliation: School of Nursing
  • Schwartz, Todd
    • Affiliation: School of Nursing
  • Verbiest, Sarah
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
  • Bonuck, Karen
    • Other Affiliation: Albert Einstein College of Medicine
  • Goodnight, William
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Rex Healthcare Inc
  • Brody, Seth
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: WakeMed Health & Hospitals
  • Dorman, Karen F
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
  • Menard, Mary K
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
  • Stuebe, Alison
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
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
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Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Diane C Berry et al.; licensee BioMed Central Ltd.
License
Journal title
  • BMC Pregnancy and Childbirth
Journal volume
  • 13
Journal issue
  • 1
Page start
  • 184
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1471-2393
Bibliographic citation
  • BMC Pregnancy and Childbirth. 2013 Oct 10;13(1):184
Publisher
  • BioMed Central Ltd
Access right
  • Open Access
Date uploaded
  • July 16, 2016

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