Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gestational diabetes; women; infants; blood glucose; weight; adiposity; health behaviors; self-efficacy