Education Nutritional Video for Gestational Diabetics

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Behavioral: Nutritional Video

• Registration Number: NCT03859193
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2019-09-27
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video	Nutritional Video	Participants will watch an Nutritional video at their first high risk visit. Participants will also receive standard nutrition counseling

Primary Outcome Measures

Name	Time	Method
Change in nutritional knowledge	Baseline to 1 week	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.

Secondary Outcome Measures

Name	Time	Method
Problem Areas In Diabetes (PAID) questionnaire Score	1 week	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
Patient Satisfaction with Care	1 week	Patient satisfaction on a scale of 1 to 5

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States