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Education Nutritional Video for Gestational Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859193
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Nutritional Video Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard care
Experimental: Video
Participants will watch an Nutritional video at their second high risk visit
Behavioral: Nutritional Video
A 10 - 15 minute video




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gestational weight change [ Time Frame: Baseline to time of delivery ]
    Change in weight from initial survey till delivery of fetus (kg)

  2. Mode of Delivery [ Time Frame: Delivery ]
    Vaginal Delivery, Cesarean Section or Operative Vaginal Delivery

  3. Weight of Fetus [ Time Frame: Time of Delivery ]
    Weight of fetus at time of delivery (kg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women with a diagnosis of Diabetes in Pregnancy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Deborah Koehn, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03859193    
Other Study ID Numbers: HM20014445
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases