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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: Low Glycemic Index Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannan Grant, PhD, PDt; Phone Number: 902-457-5400; Email: shannan.grant2@msvu.ca
• Study Contact Backup: Name: Julianne Leblanc, BSc; Phone Number: (902)470-6532; Email: julianne.leblanc@iwk.nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Centre
      • Contact: Shannan Grant, PDt,MSc,PhD; Phone Number: (902)457-5400; Email: shannan.grant@iwk.nshealth.ca
      • Contact: Julianne LeBlanc, MSc Student; Phone Number: (902)470-6532; Email: julianne.leblanc@iwk.nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: IWK Health Centre
• Collaborators: The Hospital for Sick Children; Dalhousie University; Mount Saint Vincent University
• Investigators: Principal Investigator: Shannan Grant, PhD, PDt, IWK Health Centre

Publications and helpful links

General Publications

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available. Erratum In: Can J Diabetes. 2018 Jun;42(3):337.
• Draffin CR, Alderdice FA, McCance DR, Maresh M, Harper Md Consultant Physician R, McSorley O, Holmes VA. Exploring the needs, concerns and knowledge of women diagnosed with gestational diabetes: A qualitative study. Midwifery. 2016 Sep;40:141-7. doi: 10.1016/j.midw.2016.06.019. Epub 2016 Jun 29.
• Layes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.
• Grant SM, Wolever TMS. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-340. doi: 10.3390/nu3030330. Epub 2011 Feb 28.
• Johnston S, Coyer FM, Nash R. Kirkpatrick's Evaluation of Simulation and Debriefing in Health Care Education: A Systematic Review. J Nurs Educ. 2018 Jul 1;57(7):393-398. doi: 10.3928/01484834-20180618-03.

Helpful Links

• Statistics Canada: Diabetes (2017)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2019
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Education; Gestational Diabetes; Behaviour; Glycaemic or Glycemic Index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: GI in GDM Online

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