Clinical trial NCT03947073: Gestation Diabetes N'Teractive Media-based Education (GDnME)
Official title: Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Media
Education
Gestational diabetes
Pregnancy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a prospective randomized controlled trial. Subjects with newly diagnosed gestational diabetes will be randomized to either standard of care diabetes education versus standard of care plus an interactive educational application.

Detailed description: Gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to rise. Diet and exercise can effectively control blood sugar levels in 70-85% of women diagnosed with gestational diabetes according to the American Diabetes Association. At the investigator's institution, only 50-54% of women with this diagnosis effectively reach the target blood sugar levels with diet and exercise alone. This has become a more commonly seen problem throughout the US. Those that fail to achieve target blood sugar levels require medication and have higher risks of poor maternal and neonatal outcomes. Studies have shown that an increase in education can increase compliance to diet and education. Specifically, media based education that are interactive may more effectively lead to changes in a person's behavior.

Eligibility criteria: Inclusion Criteria:

* Obtaining prenatal care in the Ambulatory Care Network (ACN)
* Speaks either English or Spanish
* Newly diagnosed with gestational diabetes between 24-32 weeks
* Will deliver at CUIMC's main institutions, Children's Hospital of New York (CHONY) or the Allen Hospital.

Exclusion Criteria:

* Diagnosed with a fetal anomaly
* Have multiple gestation
* Known diagnosis of pregestational diabetes

Primary outcomes:
measure: Total number of women who failed management with diet alone
timeFrame: Up to 42 weeks
Secondary outcomes:
measure: A1C Level
timeFrame: Up to 42 weeks
measure: Average fasting blood sugar level
timeFrame: Up to 42 weeks
measure: Average 2 hour post-prandial blood sugar level
timeFrame: Up to 42 weeks
measure: Total insulin requirement
timeFrame: Up to 42 weeks
measure: Total metformin requirement
timeFrame: Up to 42 weeks
measure: Total number of women who develop gestational hypertension
timeFrame: Up to 42 weeks
measure: Total number of women who develop pre-eclampsia
timeFrame: Up to 42 weeks
measure: C-section rate
timeFrame: Up to 42 weeks
measure: Difference in weight
timeFrame: Up to 42 weeks
measure: Total number of neonates with shoulder dystocia
timeFrame: Up to 42 weeks
measure: Total number of neonates with a NICU admission
timeFrame: Up to postpartum day 7
measure: Total number of neonates with neonatal hypoglycemia
timeFrame: Up to postpartum day 7
measure: Total number of neonates with neonatal respiratory distress syndrome
timeFrame: Up to postpartum day 7
measure: Total number of neonates with jaundice
timeFrame: Up to postpartum day 7
measure: Total number of neonates with an Apgar score <7
timeFrame: Up to 42 weeks
measure: Total number of neonates with a preterm birth
timeFrame: Up to 36 weeks and 6 days of gestation
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Noelia Zork, MD
role: PRINCIPAL_INVESTIGATOR
References: