Gestational Diabetes
Conditions
Keywords
gestational diabetes, women, infants, blood glucose, weight, adiposity, health behaviors, self-efficacy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose | Baseline to 10 months postpartum | Change in fasting blood glucose in mothers |
| weight (body mass index) | Baseline to 10 months postpartum | Change in weight (body mass index)in mothers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| homeostasis model assessment | Baseline to 10 months postpartum | Change in homeostasis model assessment calculation in mothers |
| hemoglobin A1c | Baseline to 10 months postpartum | Change in hemoglobin A1c in mothers |
| complete lipid panel | Baseline to 10 months postpartum | Change in complete lipid panel in mothers |
| blood pressure | Baseline to 10 months postpartum | Change in blood pressure in mothers |
| oral glucose tolerance test | Baseline to 10 months postpartum | Change in oral glucose tolerance test in mothers |
| health behaviors | Baseline to 10 months postpartum | Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers |
| self-efficacy | Baseline to 10 months postpartum | Change in self-efficacy in mothers |
| infant weight status | Birth to 10 months | weight status (weight-for-length) in children |
| breastfeeding | Birth to 10 months | Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants |
| adiposity | Baseline to 10 months | Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers |
| insulin levels | Baseline to 10 months postpartum | Change in insulin levels in mothers |
Countries
United States
Outcome results
None listed