CClinicalTrials.gg
CompletedNCT03859193Updated Jul 3, 2023

Education Nutritional Video for Gestational Diabetics

An interventional study of Nutritional Video in Gestational Diabetes, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Gestational Diabetes

Browse trials for

03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 42 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Any diagnosis of Diabetes in Pregnancy
  • Received at least one session of nutritional counseling from the registered dieticians

Exclusion criteria

Exclusion Criteria:

  • Age \< 18
  • Patients without diagnosis of diabetes
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • No intervention
    Standard care

    Participants will receive standard nutrition counseling

  • Experimental
    Video

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

    Behavioral: Nutritional Video

Interventions

  • BehavioralNutritional Video

    A 10 - 15 minute video

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 1 week

Secondary outcomes

  1. 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

    Time frame: 1 week

  2. Patient Satisfaction with Care

    Patient satisfaction on a scale of 1 to 5

    Time frame: 1 week

07

Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03859193
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Sep 27, 2019
Primary completion
Nov 2, 2022
Completion
Nov 2, 2022
Last update
Jul 3, 2023

Study contacts

Deborah Koehn, MD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion