Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

Gestational Diabetes Clinical Trial

Official title:

Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809431
• Other study ID #: 12-0486
• Secondary ID: 1R21DK092750-01A
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Intervention
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.

Locations

Country	Name	City	State
United States	UNC-Rex Health Care	Raleigh	North Carolina
United States	WakeMed	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting blood glucose	Change in fasting blood glucose in mothers	Baseline to 10 months postpartum
Primary	weight (body mass index)	Change in weight (body mass index)in mothers	Baseline to 10 months postpartum
Secondary	oral glucose tolerance test	Change in oral glucose tolerance test in mothers	Baseline to 10 months postpartum
Secondary	insulin levels	Change in insulin levels in mothers	Baseline to 10 months postpartum
Secondary	homeostasis model assessment	Change in homeostasis model assessment calculation in mothers	Baseline to 10 months postpartum
Secondary	hemoglobin A1c	Change in hemoglobin A1c in mothers	Baseline to 10 months postpartum
Secondary	complete lipid panel	Change in complete lipid panel in mothers	Baseline to 10 months postpartum
Secondary	blood pressure	Change in blood pressure in mothers	Baseline to 10 months postpartum
Secondary	adiposity	Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers	Baseline to 10 months
Secondary	health behaviors	Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers	Baseline to 10 months postpartum
Secondary	self-efficacy	Change in self-efficacy in mothers	Baseline to 10 months postpartum
Secondary	infant weight status	weight status (weight-for-length) in children	Birth to 10 months
Secondary	breastfeeding	Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants	Birth to 10 months