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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
Sponsor:
Collaborators:
Mount Saint Vincent University
Dalhousie University
The Hospital for Sick Children
Information provided by (Responsible Party):
Shannan Grant, IWK Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: Low Glycemic Index Education Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Knowledge/KM Level 2: Learning [ Time Frame: From baseline to 4-6 weeks postpartum ]
    Average Quiz Score: Close-ended format, Scored by correct answers.

  3. 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.

  4. 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)

  5. Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status) [ Time Frame: Baseline ]
    Mixed-form Questionnaire (GIQ) and Medical Chart

  6. Maternal Height [ Time Frame: Baseline ]
    Medical Record, measured in cm.

  7. Maternal Pre-Pregnancy body weight [ Time Frame: Baseline ]
    Medical Record, measured in kg.

  8. Maternal Weight, during pregnancy [ Time Frame: From Baseline to 4-6 weeks post-partum. ]
    Medical Record, measured in kg.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shannan Grant, PhD, PDt 902-457-5400 shannan.grant2@msvu.ca
Contact: Julianne Leblanc, BSc (902)470-6532 julianne.leblanc@iwk.nshealth.ca

Locations
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Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Shannan Grant, PDt,MSc,PhD    (902)457-5400    shannan.grant@iwk.nshealth.ca   
Contact: Julianne LeBlanc, MSc Student    (902)470-6532    julianne.leblanc@iwk.nshealth.ca   
Sponsors and Collaborators
IWK Health Centre
Mount Saint Vincent University
Dalhousie University
The Hospital for Sick Children

Additional Information:
Publications:
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Responsible Party: Shannan Grant, Affiliated Scientist, IWK Health Centre
ClinicalTrials.gov Identifier: NCT04272840    
Other Study ID Numbers: GI in GDM Online
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannan Grant, IWK Health Centre:
Gestational Diabetes
Glycaemic or Glycemic Index
Nutrition
Education
Behaviour
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications