The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Increasing evidence supports the benefit of following a low glycaemic index (GI) diet in GDM and the Canadian Diabetes Guidelines recommends replacing high GI foods for low GI foods. Despite recommendation to adapt a low GI diet in GDM, there are limitations and barriers recognized to GI utility largely focused on knowledge translation. There is sufficient research to support a low GI diet in benefiting outcomes of GDM, therefore the GI in GDM Online trial will investigate the feasibility and effectiveness of a distance low GI education intervention, adapted from Diabetes Canada's GI materials, on producing a difference in average dietary GI between a group with the intervention and standard care.

Detailed Description
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The incidence of Gestational Diabetes Mellitus (GDM) has been progressively increasing worldwide, with a global prevalence of gestational hyperglycaemia estimated at 16.9%. In Canada, Atlantic provinces have been recorded with the highest prevalence of diabetes at 6%. The Diabetes Canada Practice Guidelines recommends the low glycemic index (GI) diet to type 1 and 2 diabetes mellitus and has recently updated its guidelines to include a recommendation for GDM. This said, barriers to GI knowledge translation have been identified. This study uses a prospective parallel randomized control trial design. Procedures and materials have been adapted from NCT01589757. The Kirkpatrick Model (Reaction, Learning, Behaviour, and Results) informed intervention development and evaluation strategies. The purpose of this study is to evaluate whether a distance low GI education intervention, adapted from Diabetes Canada's GI education materials, will significantly yield a lower average GI (primary outcome) in participants than traditional standard care medical nutrition therapy for Gestational Diabetes Mellitus. We hypothesize that participants who receive the low GI intervention will have a lower dietary GI than those who received usual IWK standard care for GDM.

Official Title
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Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Low Glycemic Index Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Of or over 18 years of age Diagnosed with GDM according to Diabetes Canada At or over than 20 weeks gestation At or less than 32 weeks gestation Being followed at IWK Health Centre Willing and able to give informed consent Willing and able to complete study protocol Currently living in Nova Scotia Exclusion Criteria; women who: have been diagnosed with acute or chronic illness, other than GDM and PCOS, that may impact carbohydrate digestion metabolism. are currently taking a medication (other than insulin) that may affect carbohydrate metabolism. have multi-fetal pregnancy in current pregnancy. have insurmountable language barriers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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<br>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<br>* Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfer/KM Level 3: Change in average dietary GI | Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum | From baseline to 4-6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction/ KM Level 1: Reaction | Mixed form Questionnaire (GIQ): Close ended format with True or False, Multiple Choice, and Likert Scale choices. Open-ended questions for feedback. | From baseline to 4-6 weeks postpartum | 
| Knowledge/KM Level 2: Learning | Average Quiz Score: Close-ended format, Scored by correct answers. | From baseline to 4-6 weeks postpartum | 
| Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change) | Mixed form Questionnaire (GIQ): Close ended format using Likert Scale and True or False choices. Open-ended questions for feedback. | From 4-6 weeks post-intervention to 4-6 weeks post-partum | 
| Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range) | Medical Record (standard care 2-4 time-points per day) | From Baseline to 4-6 weeks post-partum | 
| Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status) | Mixed-form Questionnaire (GIQ) and Medical Chart | Baseline | 
| Maternal Height | Medical Record, measured in cm. | Baseline | 
| Maternal Pre-Pregnancy body weight | Medical Record, measured in kg. | Baseline | 
| Maternal Weight, during pregnancy | Medical Record, measured in kg. | From Baseline to 4-6 weeks post-partum. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour