Gestational DiabetesNCT03859193
Education Nutritional Video for Gestational Diabetics
A study testing Nutritional Video in people with Gestational Diabetes, run by Virginia Commonwealth University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Nutritional Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any diagnosis of Diabetes in Pregnancy
- Received at least one session of nutritional counseling from the registered dieticians
Who cannot join
- Age < 18
- Patients without diagnosis of diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Gestational Diabetes
- Being tested
- Nutritional Video
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional VideoBehavioural
A 10 - 15 minute video
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Participants will receive standard nutrition counseling |
| Video | Experimental | Participants will watch an Nutritional video at their first high risk visit. Participants will also receive standard nutrition counseling Receives: Behavioral: Nutritional Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 week
Secondary outcomes (2)
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
Measured: 1 week
Patient Satisfaction with Care
Patient satisfaction on a scale of 1 to 5
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start27 Sep 2019
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Koehn, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859193
- Sponsor's protocol ID
- HM20014445
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Nutritional Video for Gestational Diabetics
- ClinicalTrials.gov ID
- NCT03859193
- Acronym / sponsor ID
- HM20014445
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Participants will receive standard nutrition counseling |
| Video | Experimental | Behavioral: Nutritional VideoParticipants will watch an Nutritional video at their first high risk visit. Participants will also receive standard nutrition counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any diagnosis of Diabetes in Pregnancy
- Received at least one session of nutritional counseling from the registered dieticians
Key exclusion criteria (2 listed)
- Age < 18
- Patients without diagnosis of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional VideoA 10 - 15 minute video | Behavioural | Video |
Primary outcome
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.
2 secondary outcomes
Problem Areas In Diabetes (PAID) questionnaire Score
Time frame: 1 week
Patient Satisfaction with Care
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Koehn, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Video in people with Gestational Diabetes, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional knowledge (time frame: Baseline to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.