Education Nutritional Video for Gestational Diabetics
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Video
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes
Eligibility Criteria
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Video
Arm Description
Participants will receive standard nutrition counseling
Participants will watch an Nutritional video at their first high risk visit. Participants will also receive standard nutrition counseling
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Patient Satisfaction with Care
Patient satisfaction on a scale of 1 to 5
Full Information
NCT ID
NCT03859193
First Posted
February 27, 2019
Last Updated
June 30, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03859193
Brief Title
Education Nutritional Video for Gestational Diabetics
Official Title
Education Nutritional Video for Gestational Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants will receive standard nutrition counseling
Arm Title
Video
Arm Type
Experimental
Arm Description
Participants will watch an Nutritional video at their first high risk visit. Participants will also receive standard nutrition counseling
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Video
Intervention Description
A 10 - 15 minute video
Primary Outcome Measure Information:
Title
Change in nutritional knowledge
Description
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.
Time Frame
Baseline to 1 week
Secondary Outcome Measure Information:
Title
Problem Areas In Diabetes (PAID) questionnaire Score
Description
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
Time Frame
1 week
Title
Patient Satisfaction with Care
Description
Patient satisfaction on a scale of 1 to 5
Time Frame
1 week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women with a diagnosis of Diabetes in Pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Koehn, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Education Nutritional Video for Gestational Diabetics
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