Clinical trial NCT01809431: Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
Official title: Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
women
infants
blood glucose
weight
adiposity
health behaviors
self-efficacy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-03-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: fasting blood glucose
timeFrame: Baseline to 10 months postpartum
measure: weight (body mass index)
timeFrame: Baseline to 10 months postpartum
Secondary outcomes:
measure: oral glucose tolerance test
timeFrame: Baseline to 10 months postpartum
measure: insulin levels
timeFrame: Baseline to 10 months postpartum
measure: homeostasis model assessment
timeFrame: Baseline to 10 months postpartum
measure: hemoglobin A1c
timeFrame: Baseline to 10 months postpartum
measure: complete lipid panel
timeFrame: Baseline to 10 months postpartum
measure: blood pressure
timeFrame: Baseline to 10 months postpartum
measure: adiposity
timeFrame: Baseline to 10 months
measure: health behaviors
timeFrame: Baseline to 10 months postpartum
measure: self-efficacy
timeFrame: Baseline to 10 months postpartum
measure: infant weight status
timeFrame: Birth to 10 months
measure: breastfeeding
timeFrame: Birth to 10 months
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: UNC-Rex Health Care
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Diane Berry, PhD, ANP-BC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Alison Stuebe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.