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Gestation Diabetes N'Teractive Media-based Education (GDnME)

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Columbia University

Status

Completed

Conditions

Gestational Diabetes

Treatments

Other: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03947073
AAAR9927

Details and patient eligibility

About

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.

Full 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.

Enrollment

199 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

199 participants in 2 patient groups

Standard of Care
No Intervention group
Description:
Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.
Interactive Educational Application
Experimental group
Description:
Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.
Treatment:
Other: Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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