Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:11/23/2013
Start Date:May 2012
End Date:April 2014
Contact:Diane C Berry, PhD, ANP-BC
Email:dberry@email.unc.edu
Phone:919-843-8561

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The purpose of this study is to determine whether a 14 week intervention is successful in
improving outcomes for women with gestational diabetes mellitus and their infants.


Women who are diagnosed with gestational diabetes are at increased risk for developing
prediabetes and type 2 diabetes. To date, there have been few interdisciplinary
interventions that target predominantly ethnic minority low-income women diagnosed with
gestational diabetes. Programs are needed that intervene in the prenatal period to teach
women the importance of breastfeeding to improve metabolic control and infant health and
continue after birth to promote improved nutrition and exercise patterns and weight loss.
Using a two-group, repeated measures experimental design, this proposed study will test a
14-week intensive intervention on the benefits of breastfeeding, understanding gestational
diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise
education, coping skills training, and physical activity (Phase I) and 3 months of continued
monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes
improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy. Trends
in breastfeeding duration and intensity, maternal infant feeding behavior, infant growth
trajectory (weight-for-length) will also be measured. A total of 100 African American,
bilingual Hispanic, and non-Hispanic White women diagnosed with gestational diabetes will be
inducted and randomized by site to either the experimental or wait-list control group. Data
will be collected at Time 1 (Baseline at 22-36 weeks pregnant), Time 2 (6 weeks postpartum),
Time 3 (4 months postpartum and completion of Phase I), Time 4 (7 months postpartum and
completion of Phase II), and Time 5 (10 months postpartum and after 3 months on their own).
Primary maternal outcomes will include fasting blood glucose and weight (BMI). Secondary
maternal outcomes will include clinical outcomes (oral glucose tolerance test, insulin
levels, Homeostasis Model Assessment calculation, Hemoglobin A1c, complete lipid panel, and
blood pressure); adiposity (waist circumference, triceps and subscapular skin folds); health
behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and
Accelerometry for 7 days); and self-efficacy (Eating Self-Efficacy, Exercise Self-Efficacy
Scale, and Breastfeeding Self-Efficacy Scale). Infant outcomes will include data on weight
status (weight-for-length) and breastfeeding (weeks until stopped breastfeeding, weeks
exclusively breastfed, and intensity of breastfeeding). Data analysis will include analysis
of field notes, post-intervention interviews, and recruitment and retention efforts. Linear
mixed-effects random coefficients models will be constructed to measure the effects of the
intervention compared to the wait-list control group. Increasing breastfeeding and
decreasing overweight in postpartum women who were diagnosed with gestational diabetes may
both improve maternal glucose homeostasis and weight and stabilize infant growth trajectory,
reducing the burden of metabolic disease across two generations.

Inclusion Criteria:

- Women between 22-36 weeks of pregnancy who are diagnosed with GDM

- A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose
Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h
155, 3h 140 mg/dL)

- Age 18-45 years old

- A pre-pregnancy body mass index > 25kg/m2

- Ability to read and write in English

- Willingness to consent for themselves and their infant

Exclusion Criteria:

- They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)
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Raleigh, North Carolina 27607
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Raleigh, North Carolina 27610
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