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Completed

NCT Number: NCT01809431

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Rex Health Care, Raleigh, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention

Behavioral

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: breastfeeding education, progression to prediabetes and type 2 diabetes education, nutrition education, exercise education, coping skills training, exercise training, home-based exercise program, educational and motivational text messaging

Primary outcomes

  1. fasting blood glucose

    Time frame: Baseline to 10 months postpartum

    Change in fasting blood glucose in mothers

  2. weight (body mass index)

    Time frame: Baseline to 10 months postpartum

    Change in weight (body mass index)in mothers

Secondary outcomes

  1. oral glucose tolerance test

    Time frame: Baseline to 10 months postpartum

    Change in oral glucose tolerance test in mothers

  2. insulin levels

    Time frame: Baseline to 10 months postpartum

    Change in insulin levels in mothers

  3. homeostasis model assessment

    Time frame: Baseline to 10 months postpartum

    Change in homeostasis model assessment calculation in mothers

  4. hemoglobin A1c

    Time frame: Baseline to 10 months postpartum

    Change in hemoglobin A1c in mothers

  5. complete lipid panel

    Time frame: Baseline to 10 months postpartum

    Change in complete lipid panel in mothers

  6. blood pressure

    Time frame: Baseline to 10 months postpartum

    Change in blood pressure in mothers

  7. adiposity

    Time frame: Baseline to 10 months

    Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers

  8. health behaviors

    Time frame: 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

  9. self-efficacy

    Time frame: Baseline to 10 months postpartum

    Change in self-efficacy in mothers

  10. infant weight status

    Time frame: Birth to 10 months

    weight status (weight-for-length) in children

  11. breastfeeding

    Time frame: Birth to 10 months

    Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2013
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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