Skip to main content
Clinical Trials/NCT01809431
NCT01809431
Completed
Not Applicable

Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

University of North Carolina, Chapel Hill2 sites in 1 country200 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
University of North Carolina, Chapel Hill
Enrollment
200
Locations
2
Primary Endpoint
fasting blood glucose
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
July 2014
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

fasting blood glucose

Time Frame: Baseline to 10 months postpartum

Change in fasting blood glucose in mothers

weight (body mass index)

Time Frame: Baseline to 10 months postpartum

Change in weight (body mass index)in mothers

Secondary Outcomes

  • homeostasis model assessment(Baseline to 10 months postpartum)
  • blood pressure(Baseline to 10 months postpartum)
  • infant weight status(Birth to 10 months)
  • hemoglobin A1c(Baseline to 10 months postpartum)
  • self-efficacy(Baseline to 10 months postpartum)
  • oral glucose tolerance test(Baseline to 10 months postpartum)
  • insulin levels(Baseline to 10 months postpartum)
  • adiposity(Baseline to 10 months)
  • complete lipid panel(Baseline to 10 months postpartum)
  • health behaviors(Baseline to 10 months postpartum)
  • breastfeeding(Birth to 10 months)

Study Sites (2)

Loading locations...

Similar Trials