The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04272840|
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus||Behavioral: Low Glycemic Index Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective Randomized Control Trial|
|Masking:||None (Open Label)|
|Official Title:||Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.|
|Actual Study Start Date :||October 24, 2019|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
No Intervention: Standard Care
Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record).
Experimental: Low Glycemic Index
Standard care + Glycemic Index. Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). Diabetes Canada and Dietitian's Canada resources on glycemic index will also be reviewed: the Glycemic Index Food Guide, Flip Cards, and Recipes.
Behavioral: Low Glycemic Index Education
Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.
- Transfer/KM Level 3: Change in average dietary GI [ Time Frame: From baseline to 4-6 weeks postpartum ]Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum
- Satisfaction/ KM Level 1: Reaction [ Time Frame: From baseline to 4-6 weeks postpartum ]Mixed form Questionnaire (GIQ): Close ended format with True or False, Multiple Choice, and Likert Scale choices. Open-ended questions for feedback.
- Knowledge/KM Level 2: Learning [ Time Frame: From baseline to 4-6 weeks postpartum ]Average Quiz Score: Close-ended format, Scored by correct answers.
- Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change) [ Time Frame: From 4-6 weeks post-intervention to 4-6 weeks post-partum ]Mixed form Questionnaire (GIQ): Close ended format using Likert Scale and True or False choices. Open-ended questions for feedback.
- Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range) [ Time Frame: From Baseline to 4-6 weeks post-partum ]Medical Record (standard care 2-4 time-points per day)
- Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status) [ Time Frame: Baseline ]Mixed-form Questionnaire (GIQ) and Medical Chart
- Maternal Height [ Time Frame: Baseline ]Medical Record, measured in cm.
- Maternal Pre-Pregnancy body weight [ Time Frame: Baseline ]Medical Record, measured in kg.
- Maternal Weight, during pregnancy [ Time Frame: From Baseline to 4-6 weeks post-partum. ]Medical Record, measured in 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): NCT04272840
|Contact: Shannan Grant, PhD, PDtfirstname.lastname@example.org|
|Contact: Julianne Leblanc, BSc||(902)email@example.com|