Education Nutritional Video for Gestational Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: Nutritional Video

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A 10 - 15 minute video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week
Patient Satisfaction with Care	Patient satisfaction on a scale of 1 to 5	1 week

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Deborah Koehn, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes, Gestational
• Other Study ID Numbers: HM20014445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No