Education Nutritional Video for Gestational Diabetics
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|ClinicalTrials.gov Identifier: NCT03859193|
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Behavioral: Nutritional Video||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Education Nutritional Video for Gestational Diabetics|
|Actual Study Start Date :||September 27, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||October 2021|
|No Intervention: Standard care|
Participants will watch an Nutritional video at their second high risk visit
Behavioral: Nutritional Video
A 10 - 15 minute video
- Change in nutritional knowledge [ Time Frame: 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.
- Gestational weight change [ Time Frame: Baseline to time of delivery ]Change in weight from initial survey till delivery of fetus (kg)
- Mode of Delivery [ Time Frame: Delivery ]Vaginal Delivery, Cesarean Section or Operative Vaginal Delivery
- Weight of Fetus [ Time Frame: Time of Delivery ]Weight of fetus at time of delivery (kg)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859193
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Deborah Koehn, MD||Virginia Commonwealth University|