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

NCT ID: NCT03947073

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2021-01-27

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interactive Educational Application

Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.

Interventions

Education

Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noelia Zork, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAR9927

Identifier Type: -

Identifier Source: org_study_id