Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-03 @ 9:19 PM
Study NCT ID:
NCT03859193
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Nutritional Video for Gestational Diabetics
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Education Nutritional Video for Gestational Diabetics
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out if watching an educational video about nutrition helps participants learn about how different foods affect their blood sugar and how Gestational Diabetes affects pregnancy.
Detailed 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 counseling or standard counseling plus educational video using block randomization that has been integrated into the Redcap Survey. Once the Initial survey is completed the RedCap program will inform the patient whether they are randomized to Video or NO Video.
* Patients randomized to Video will watch the video will watch the video on a clinic designated computer. Patients randomized to no Video will not watch a video.
* At the next High risk clinic visit one to two weeks later all patients will fill out the same fill out the same questionnaire in addition to the The Problem Areas In Diabetes (PAID) questionaire.
* 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.
* Patients will be randomized into standard counseling or standard counseling plus educational video using block randomization that has been integrated into the Redcap Survey. Once the Initial survey is completed the RedCap program will inform the patient whether they are randomized to Video or NO Video.
* Patients randomized to Video will watch the video will watch the video on a clinic designated computer. Patients randomized to no Video will not watch a video.
* At the next High risk clinic visit one to two weeks later all patients will fill out the same fill out the same questionnaire in addition to the The Problem Areas In Diabetes (PAID) questionaire.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: