Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Raleigh, North Carolina, United States, 27607
      • UNC-Rex Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Breastfeeding, progression to type 2 diabetes, nutrition, and exercise education, coping skills training, exercise training, a home-based exercise program and educational and motivational text messaging.	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.; Other Names: exercise training; breastfeeding education; progression to prediabetes and type 2 diabetes education; nutrition education; exercise education; coping skills training; home-based exercise program; educational and motivational text messaging
No Intervention: Wait-listed control group; Wait-listed control group receive usual care delivered by their health care provider and after completion of their time in the study they are offered the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose	Change in fasting blood glucose in mothers	Baseline to 10 months postpartum
weight (body mass index)	Change in weight (body mass index)in mothers	Baseline to 10 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral glucose tolerance test	Change in oral glucose tolerance test in mothers	Baseline to 10 months postpartum
insulin levels	Change in insulin levels in mothers	Baseline to 10 months postpartum
homeostasis model assessment	Change in homeostasis model assessment calculation in mothers	Baseline to 10 months postpartum
hemoglobin A1c	Change in hemoglobin A1c in mothers	Baseline to 10 months postpartum
complete lipid panel	Change in complete lipid panel in mothers	Baseline to 10 months postpartum
blood pressure	Change in blood pressure in mothers	Baseline to 10 months postpartum
adiposity	Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers	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	Baseline to 10 months postpartum
self-efficacy	Change in self-efficacy in mothers	Baseline to 10 months postpartum
infant weight status	weight status (weight-for-length) in children	Birth to 10 months
breastfeeding	Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants	Birth to 10 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill; Principal Investigator: Alison Stuebe, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Stuebe AM, Bonuck K, Adatorwovor R, Schwartz TA, Berry DC. A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Breastfeed Med. 2016 Dec;11(10):504-513. doi: 10.1089/bfm.2016.0069. Epub 2016 Oct 26.
• Berry DC, Neal M, Hall EG, Schwartz TA, Verbiest S, Bonuck K, Goodnight W, Brody S, Dorman KF, Menard MK, Stuebe AM. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study. BMC Pregnancy Childbirth. 2013 Oct 10;13:184. doi: 10.1186/1471-2393-13-184.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 10, 2013
• First Submitted That Met QC Criteria: March 10, 2013
• First Posted (Estimated): March 12, 2013

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: infants; adiposity; blood glucose; gestational diabetes; women; self-efficacy; weight; health behaviors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 12-0486; 1R21DK092750-01A1 (U.S. NIH Grant/Contract)