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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
UNC-Rex Health Care
Raleigh, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
fasting blood glucose
Change in fasting blood glucose in mothers
Time frame: Baseline to 10 months postpartum
weight (body mass index)
Change in weight (body mass index)in mothers
Time frame: Baseline to 10 months postpartum
oral glucose tolerance test
Change in oral glucose tolerance test in mothers
Time frame: Baseline to 10 months postpartum
insulin levels
Change in insulin levels in mothers
Time frame: Baseline to 10 months postpartum
homeostasis model assessment
Change in homeostasis model assessment calculation in mothers
Time frame: Baseline to 10 months postpartum
hemoglobin A1c
Change in hemoglobin A1c in mothers
Time frame: Baseline to 10 months postpartum
complete lipid panel
Change in complete lipid panel in mothers
Time frame: Baseline to 10 months postpartum
blood pressure
Change in blood pressure in mothers
Time frame: Baseline to 10 months postpartum
adiposity
Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 10 months
health behaviors
Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
Time frame: Baseline to 10 months postpartum
self-efficacy
Change in self-efficacy in mothers
Time frame: Baseline to 10 months postpartum
infant weight status
weight status (weight-for-length) in children
Time frame: Birth to 10 months
breastfeeding
Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
Time frame: Birth to 10 months