Education Nutritional Video for Gestational Diabetics

Gestational Diabetes Clinical Trial

Official title:

Education Nutritional Video for Gestational Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859193
• Other study ID #: HM20014445
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: November 2, 2022

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any diagnosis of Diabetes in Pregnancy

• Received at least one session of nutritional counseling from the registered dieticians

Exclusion Criteria:

• Age < 18

• Patients without diagnosis of diabetes

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Nutritional Video
A 10 - 15 minute video

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutritional knowledge	Change in nutritional knowledge as measured by 10-item Gestational Diabetes Mellitus Knowledge Questionnaire, each question answered correctly is counted as one towards total score. Maximum score is 10, minimum score is 0.	Baseline to 1 week
Secondary	Problem Areas In Diabetes (PAID) questionnaire Score	Respondents are asked to indicate the degree to which each of the items is currently a problem for them, from 0 (not a problem) to 4 (a serious problem). This is a 20 item questionaire and calculates a score of 1-100	1 week
Secondary	Patient Satisfaction with Care	Patient satisfaction on a scale of 1 to 5	1 week