Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Gestational Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Patients diagnosed with gestational diabetes receive standard nutritional counseling at their first high risk clinic visit. All patients agreeing to participate in the study will at this visit fill out a knowledge questionnaire prior to receiving counseling. Patients will be randomized into standard...

Patients diagnosed with gestational diabetes receive standard nutritional counseling at their first high risk clinic visit. All patients agreeing to participate in the study will at this visit fill out a knowledge questionnaire prior to receiving counseling. Patients will be randomized into standard counseling or standard counseling plus educational video using sealed envelopes that have been randomized by a computer generator and labeled for example #1 - #100 based on order enrolled in study. The envelope will have a piece of paper with video or no video At the next High risk clinic visit one week later patients randomized to the educational video will watch the video on a clinic designated computer after being checked in by nursing. They will then fill out the same questionnaire. Patients that are randomized to no video will only refill out the questionnaire English-speaking patients will view the English version of the video, and Spanish-speaking patients will view the Spanish version of the video in either English or the dubbed Spanish version. A Spanish version of the patient hand-out will be provided in an amendment, prior to their use with Spanish- speaking patients.

Tracking Information

NCT #
NCT03859193
Collaborators
Not Provided
Investigators
Principal Investigator: Deborah Koehn, MD Virginia Commonwealth University